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20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants

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ClinicalTrials.gov Identifier: NCT04382326
Recruitment Status : Completed
First Posted : May 11, 2020
Results First Posted : December 6, 2023
Last Update Posted : December 6, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants

Condition or disease Intervention/treatment Phase
Pneumococcal Disease Biological: 20-valent pneumococcal conjugate vaccine Biological: 13-valent pneumococcal conjugate vaccine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1997 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
Actual Study Start Date : May 20, 2020
Actual Primary Completion Date : September 2, 2022
Actual Study Completion Date : September 2, 2022

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MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: 20-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
 Biological: 20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
Active Comparator: 13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
 Biological: 13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Local Reactions Within 7 Days After Dose 1 [ Time Frame: Within 7 days after Dose 1 ]
    Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

  2. Percentage of Participants With Local Reaction Within 7 Days After Dose 2 [ Time Frame: Within 7 Days After Dose 2 ]
    Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

  3. Percentage of Participants With Local Reactions Within 7 Days After Dose 3 [ Time Frame: Within 7 days after Dose 3 ]
    Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

  4. Percentage of Participants With Local Reactions Within 7 Days After Dose 4 [ Time Frame: Within 7 days after Dose 4 ]
    Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method.

  5. Percentage of Participants With Systemic Events Within 7 Days After Dose 1 [ Time Frame: Within 7 days after Dose 1 ]
    Systemic events included fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature greater than or equal to (>=) 38.0 degrees Celsius (C) and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.

  6. Percentage of Participants With Systemic Events Within 7 Days After Dose 2 [ Time Frame: Within 7 days after Dose 2 ]
    Systemic events included fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature >= 38.0 degrees C and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.

  7. Percentage of Participants With Systemic Events Within 7 Days After Dose 3 [ Time Frame: Within 7 days after Dose 3 ]
    Systemic events included fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature >= 38.0 degrees C and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.

  8. Percentage of Participants With Systemic Events Within 7 Days After Dose 4 [ Time Frame: Within 7 days after Dose 4 ]
    Systemic events included fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature >= 38.0 degrees C and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.

  9. Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 [ Time Frame: From Dose 1 to 1 Month after Dose 3 ]
    An AE was any untoward medical occurrence in a participants, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events.

  10. Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4 [ Time Frame: From Dose 4 to 1 month after Dose 4 ]
    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events.

  11. Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 6 Months Following Dose 4 [ Time Frame: From Dose 1 to 6 months following Dose 4 ]
    A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.

  12. Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 6 Months Following Dose 4 [ Time Frame: From Dose 1 to 6 months following Dose 4 ]
    An NDCMC was defined as a significant disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method.

  13. Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 [ Time Frame: 1 month after Dose 3 ]
    Pre-specified levels of serotypes were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: >=0.35 microgram per mL (mcg/mL), for serotype 5: >=0.23 mcg/mL, for serotype 6B: >=0.10 mcg/mL and for serotype 19A: >=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.

  14. Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4 [ Time Frame: From Dose 1 to 6 months following Dose 4 ]
    Concentrations of anticapsular IgG for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in all participants at 1 month after Dose 4 using the Luminex assay. Results were expressed as IgG concentrations. GMCs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution. Assay result below LLOQ was set to 0.5*LLOQ. Geometric mean ratios (GMRs) were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CIs (based on Student's t distribution).

  15. Percentage of Participants With Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens 1 Month After Dose 3 [ Time Frame: 1 month after Dose 3 ]
    Concentration of antibody to diphtheria toxoid (predefined level ≥0.1 IU/mL), tetanus toxoid (predefined level ≥0.1 IU/mL), IgG antibodies to pertussis antigens (pertussis toxin, filamentous hemagglutinin and pertactin, each with the predefined level as the 5th percentile observed in the 13vPnC group), hepatitis B antibody (in milli-international units per mL [mIU/mL]) (predefined level ≥10 mIU/mL), neutralizing antibody (NA) titers to poliovirus types 1, 2, and 3 (predefined level NA titer ≥1:8), Haemophilus influenzae type b (Hib) (≥0.15 μg/mL) were determined on subsets of sera collected at the immunogenicity time point 1 month after Dose 3. The antibody levels were measured by a validated multiplex Luminex immunoassay. The concomitant immune responses were measured on random subsets.


Secondary Outcome Measures :
  1. Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3 [ Time Frame: 1 month after Dose 3 ]
    Pneumococcal IgG antibody against each of the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F) was measured using direct binding Luminex assay. Results were expressed as IgG concentrations. GMCs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution. Assay result below LLOQ were set to 0.5*LLOQ.GMRs were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CI (based on Student's t distribution). Assay result below LLOQ were set to 0.5*LLOQ.GMRs were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CI (based on Student's t distribution).

  2. Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4 [ Time Frame: 1 month after Dose 4 ]
    Pre-specified levels of serotypes were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: >=0.35 microgram per mL (mcg/mL), for serotype 5: >=0.23 mcg/mL, for serotype 6B: >=0.10 mcg/mL and for serotype 19A: >=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.

  3. Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3 [ Time Frame: 1 month after Dose 3 ]
    OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomized subsets of participants at 1 month after Dose 3. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution. OPA titers were determined in randomized subsets of participants at 1 month after Dose 3.

  4. Serotype-specific OPA GMTs at 1 Month After Dose 4 [ Time Frame: 1 month after Dose 4 ]
    OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomized subsets of participants at 1 month after Dose 4. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution. OPA titers were determined in randomized subsets of participants at 1 month after Dose 4.

  5. Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4 [ Time Frame: 1 month after Dose 3 to before Dose 4 ]
    GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F. The GMFR from 1 month after Dose 3 to before Dose 4 were reported from Dose 3 evaluable immunogenicity participant.

  6. Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4 [ Time Frame: From 1 month before to 1 month after Dose 4 ]
    GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F. The GMFR from 1 month before Dose 4 to 1 month after Dose 4 were reported from Dose 4 evaluable immunogenicity participants.

  7. Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4 [ Time Frame: from 1 month after Dose 3 to 1 month after Dose 4 ]
    GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F. The GMFR from 1 month after Dose 3 to 1 month after Dose 4 were reported from participants in both Dose 3 and Dose 4 evaluable immunogenicity populations.

  8. Percentage of Participants With Alternative Prespecified Hib Antibody Level 1 Month After Dose 3 [ Time Frame: 1 month after Dose 3 ]
    Antibody concentration to the Hib vaccine antigens were determined on sera collected from a randomly selected subset of participants with sufficient sera volumes. Percentage of participants with alternative prespecified Hib antibody (≥1.0 μg/mL) were reported from Dose 3 evaluable immunogenicity participants.

  9. Geometric Mean Ratios (GMRs) of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigen (Measles) 1 Month After Dose 4 [ Time Frame: 1 month after Dose 4 ]
    Antibody concentrations to concomitant vaccine antigen (measles) were determined on sera collected 1 month after Dose 4 from a randomly selected subset of participants with sufficient sera volumes. GMs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution and were reported from Dose 4 evaluable immunogenicity participants.

  10. GMRs of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigen (Mumps) 1 Month After Dose 4 [ Time Frame: 1 month after Dose 4 ]
    Antibody concentrations to concomitant vaccine antigen (mumps) were determined on sera collected 1 month after Dose 4 from a randomly selected subset of participants with sufficient sera volumes. GMs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution and were reported from Dose 4 evaluable immunogenicity participants.

  11. GMRs of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens (Rubella) 1 Month After Dose 4 [ Time Frame: 1 month after Dose 4 ]
    Antibody concentrations to concomitant vaccine antigen (rubella) were determined on sera collected 1 month after Dose 4 from a randomly selected subset of participants with sufficient sera volumes. GMs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution and were reported from Dose 4 evaluable immunogenicity participants.

  12. GMRs of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigen (Varicella) 1 Month After Dose 4 [ Time Frame: 1 month after Dose 4 ]
    Antibody concentrations to concomitant vaccine antigen (varicella) were determined on sera collected 1 month after Dose 4 from a randomly selected subset of participants with sufficient sera volumes. GMs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution and were reported from Dose 4 evaluable immunogenicity participants.


Eligibility Criteria
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Ages Eligible for Study:   42 Days to 98 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female infants born at >36 weeks of gestation and 2 months of age at the time of consent.
  • Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion Criteria:

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
  • Major known congenital malformation or serious chronic disorder
  • Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results
  • Previous receipt of >1 dose of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at >30 days old, or previous receipt of any licensed or investigational pneumococcal vaccine, or planned receipt through study participation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04382326


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] April 1, 2022
Statistical Analysis Plan  [PDF] May 19, 2022

More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04382326    
Other Study ID Numbers: B7471011
2019-003305-10 ( EudraCT Number )
First Posted: May 11, 2020    Key Record Dates
Results First Posted: December 6, 2023
Last Update Posted: December 6, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
 Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs