20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN AS A SERIES OF 2 INFANT DOSES AND 1 TODDLER DOSE IN HEALTHY INFANTS

ClinicalTrials.gov ID

NCT04546425

Acronym / sponsor ID

B7471012

Conditions

Pneumococcal Disease

Phase

Phase 3

Study type

Interventional

Recruitment status

Completed

Enrolment

1,258 participants (actual)

Lead sponsor

PfizerIndustry (pharma, biotech, devices)

Study start

9 Sep 2020 (actual)

Primary completion

22 Apr 2022 (actual)

Study completion

18 Feb 2023 (actual)

First posted

14 Sep 2020 (actual)

Results

Posted 15 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Prevention

Allocation

Randomised

Intervention model

Parallel groups

Masking

Quadruple blind (participant, care provider, investigator, outcomes assessor)

Number of arms

2

Who may qualify

Ages

42 to 112 days

Sex

All

Healthy volunteers

Accepted

Age groups

Child

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population

   Time frame: Within 7 days after Dose 1

   Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 0 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.

2. Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population

   Time frame: Within 7 days after Dose 2

   Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0 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% CI was based on Clopper and Pearson method.

3. Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population

   Time frame: Within 7 days after Dose 3

   Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0 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% CI was based on Clopper and Pearson method.

4. Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population

   Time frame: Within 7 Days after Dose 1

   Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: was defined as temperature >=38.0 degree Celsius (C) and categorized as >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.

5. Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population

   Time frame: Within 7 Days after Dose 2

   Systemic events: 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 degree C and categorized as >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: 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 3: Primary Study Population

   Time frame: Within 7 Days after Dose 3

   Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: was defined as temperature >=38.0 degree C and categorized as >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) \& severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: 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 Adverse Events (AEs) From Dose 1 to 1 Month After Dose 2: Primary Study Population

   Time frame: From Dose 1 to 1 month after Dose 2

   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 collected from an e-diary.

8. Percentage of Participants With Adverse Events (AEs) From Dose 3 to 1 Month After Dose 3: Primary Study Population

   Time frame: From Dose 3 to 1 month after Dose 3

   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 collected from an e-diary.

9. Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 3: Primary Study Population

   Time frame: From Dose 1 to 1 month after Dose 3

   A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.

10. Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Dose 1 to 1 Month After Dose 3: Primary Study Population

    Time frame: From Dose 1 to 1 month after Dose 3

    A NDCMC was defined as a 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.

11. Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population

    Time frame: 1 month after Dose 2

    Predefined IgG concentrations 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.

12. Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population

    Time frame: 1 month after Dose 2

    Pneumococcal serotype-specific IgG concentration was measured for serum sample for 13vPnC serotype: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 7 additional serotype: 8, 10A, 11A, 12F, 15B, 22F, 33F. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, corresponding 2-sided 95% CIs (based on 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).

13. GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population

    Time frame: 1 month after Dose 3

    Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 7 additional serotype: 8, 10A, 11A, 12F, 15B, 22F,33F. GMC and corresponding 2-sided 95% CI were calculated by exponentiating mean logarithm of concentrations 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).

14. Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population

    Time frame: 1 month after Dose 3

    Diphtheria and tetanus toxoids: concentration of antibody (AB) (in international units [IU]) to diphtheria \& tetanus toxoid (prespecified level>=0.1 IU/mL); Pertussis antigens-pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (PRN): prespecified level >=observed Anti pertussis Antibody concentration achieved by 95% of 13vPnC recipient; HBsAg prespecified level >=10 milli-IU per mL (mIU/mL); Poliovirus strains (types 1, 2 and 3): prespecified level: >=1:8; Hemophilus influenzae type b(Hib): prespecified level >=0.15 microgram per millilitre (mcg/mL) polyribosylribitol phosphate (anti-PRP) in mcg/mL. Concomitant vaccine response was assessed from subset of randomly selected study participants.

15. GMC of Measles Virus Antibody 1 Month After Dose 3: Primary Study Population

    Time frame: 1 month after Dose 3

    Pre-specified vaccine antigen (measles) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.

16. GMC of Mumps Virus Antibody 1 Month After Dose 3: Primary Study Population

    Time frame: 1 month after Dose 3

    Pre-specified vaccine antigen (mumps) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.

17. GMC of Rubella Virus Antibody 1 Month After Dose 3: Primary Study Population

    Time frame: 1 month after Dose 3

    Pre-specified vaccine antigen (rubella) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below LLOQ were set to 0.5*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.

18. GMC of Varicella Virus Antibody 1 Month After Dose 3: Primary Study Population

    Time frame: 1 month after Dose 3

    Pre-specified vaccine antigen (varicella) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.

19. Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort

    Time frame: Within 7 days after Dose 1

    Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0 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% CI was based on Clopper and Pearson method.

20. Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort

    Time frame: Within 7 days after Dose 2

    Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0 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% CI was based on Clopper and Pearson method.

21. Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort

    Time frame: Within 7 days after Dose 3

    Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0 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% CI was based on Clopper and Pearson method.

22. Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort

    Time frame: Within 7 Days after Dose 1

    Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using e-diary. Fever: temperature >=38.0 degree C \& categorized as >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0-degree 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/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper \& Pearson method.

23. Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort

    Time frame: Within 7 Days after Dose 2

    Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: temperature >=38.0 degree C and categorized as >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper \& Pearson method.

24. Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort

    Time frame: Within 7 Days after Dose 3

    Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: temperature >=38.0 degree C and categorized as >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper \& Pearson method.

25. Percentage of Participants With AEs From Dose 1 to 1 Month After Dose 2: Russian Cohort

    Time frame: From Dose 1 to 1 month after Dose 2

    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 collected from an e-diary.

26. Percentage of Participants With AEs From Dose 3 to 1 Month After Dose 3: Russian Cohort

    Time frame: From Dose 3 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 collected from an e-diary.

27. Percentage of Participants With SAEs From Dose 1 to 1 Month After Dose 3: Russian Cohort

    Time frame: From Dose 1 to 1 month after Dose 3

    A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.

28. Percentage of Participants With NDCMC From Dose 1 to 1 Month After Dose 3: Russian Cohort

    Time frame: From Dose 1 to 1 month after Dose 3

    A NDCMC was defined as a 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.

29. Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort

    Time frame: 1 month after Dose 2

    Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: >=0.35 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.

30. GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort

    Time frame: 1 month after Dose 2

    Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F and 7 additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, 33F. Assay results below the LLOQ were set to 0.5 * LLOQ. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, and the corresponding 2-sided 95% CIs (based on Student's t distribution).

31. GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort

    Time frame: 1 month after Dose 3

    Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F and additional serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. Assay results below the LLOQ were set to 0.5 * LLOQ. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, and the corresponding 2-sided 95% CIs (based on Student's t distribution).

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 41187484Senders S, Korbal P, Kline M, Tamimi N, Thompson A, Drozd J, Cutler MW, Giardina PC, Trammel J, Lei L, Peng Y, Watson W, McElwee K. Immunogenicity and safety of concomitant vaccines given with 20-valent pneumococcal conjugate vaccine in healthy infants. Vaccine. 2025 Dec 5;68:127916. doi: 10.1016/j.vaccine.2025.127916. Epub 2025 Nov 3.
• Derived from this study: PubMed 38456705Korbal P, Wysocki J, Jackowska T, Kline M, Tamimi N, Drozd J, Lei L, Peng Y, Giardina PC, Gruber W, Scott D, Watson W. Phase 3 Safety and Immunogenicity Study of a Three-dose Series of Twenty-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers. Pediatr Infect Dis J. 2024 Jun 1;43(6):587-595. doi: 10.1097/INF.0000000000004300. Epub 2024 Mar 8.
• To obtain contact information for a study center near you, click here.Link provided by the sponsor.
• Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

66 sites in 12 countries: see every site and its status.