A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months

NCT06622109 | Active Not Recruiting

• 2 other identifiers: B7471035NCT06622109
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn about the safety of 20-valent Pneumococcal Conjugate Vaccine (PREVENAR 20) under actual clinical practice in Japan. This study is seeking for infants aged between two months to six months who are vaccinated with PREVENAR 20 for the first time. Infants aged between two months and six months are normally given four vaccinations. The first three vaccinations are called primary vaccinations and are given with an interval of one month between each vaccination. The fourth vaccination is called the booster and is given between 12 and 15 months of age. Participants will take part in this study from the day of first vaccination to 28 days after fourth vaccination. The side effects observed in the participants will be recorded and looked into.

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Reporting Adverse Reactions(ADRs)

  From the first day of each vaccination (1st-4th) up to 28 days after each vaccination (1st-4th).

• Percentage of Participants Reporting Serious Adverse Reactions (SADRs)

  From the first day of 1st vaccination up to 28 days after 4th vaccination.

Study Arms (1)

20-valent Pneumococcal Conjugate Vaccine

Infants aged 2 months, inclusive to 7 months, exclusive who have been vaccinated with PREVENAR 20 for the first time.

Biological: 20-valent Pneumococcal Conjugate Vaccine

Interventions

20-valent Pneumococcal Conjugate Vaccine BIOLOGICAL

Injection in the muscle or subcutaneous , 1 dose 0.5mL

20-valent Pneumococcal Conjugate Vaccine

Eligibility Criteria

• Age: 2 Months - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Infants aged 2 months, inclusive, to 7 months, exclusive who PREVENAR 20 for the first time.

You may qualify if:

• Infants aged 2 months, inclusive, to 7 months, exclusive
• Those without a history of pneumococcal vaccination including PREVENAR 20
• Those who are expected to receive 4 doses
• Those whose parent or legal guardian understands the details of the study and provides consent to provision of information collected in the study to third parties and use of the information for other purposes.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Tokyo, 151-8589, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2024
• First Posted: October 1, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)