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

Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2023. 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 IN HEALTHY INFANTS

ClinicalTrials.gov ID

NCT04382326

Acronym / sponsor ID

B7471011

Conditions

Pneumococcal Disease

Phase

Phase 3

Study type

Interventional

Recruitment status

Completed

Enrolment

1,997 participants (actual)

Lead sponsor

PfizerIndustry (pharma, biotech, devices)

Study start

20 May 2020 (actual)

Primary completion

2 Sep 2022 (actual)

Study completion

2 Sep 2022 (actual)

First posted

11 May 2020 (actual)

Results

Posted 6 Dec 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 98 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

   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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
• 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 38535409Senders S, Klein NP, Tamimi N, Thompson A, Baugher G, Trammel J, Peng Y, Giardina P, Scully IL, Pride M, Center KJ, Gruber WC, Scott DA, Watson W. A Phase Three Study of the Safety and Immunogenicity of a Four-dose Series of 20-Valent Pneumococcal Conjugate Vaccine in Healthy Infants. Pediatr Infect Dis J. 2024 Jun 1;43(6):596-603. doi: 10.1097/INF.0000000000004334. Epub 2024 Mar 26.
• Derived from this study: PubMed 37846456Mt-Isa S, Chumbley JR, Crawford EL, Banniettis N, Buchwald UK, Weaver J, Weiss T. An indirect treatment comparison (ITC) and matching-adjusted indirect comparison (MAIC) between a 15-valent (V114) and a 20-valent (PCV20) pneumococcal conjugate vaccine among healthy infants. Expert Rev Vaccines. 2023 Jan-Dec;22(1):906-917. doi: 10.1080/14760584.2023.2270039. Epub 2023 Oct 19.
• 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.

110 sites in 2 countries: see every site and its status.