Completed

13vPnC vs 7vPnC: Safety and Immunogenicity in Healthy Infants

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Study Aim

This phase 3 study aims to evaluate the safety and effectiveness of two different pneumococcal vaccines (13vPnC and 7vPnC) in healthy infants, by measuring the level of specific antibodies produced after vaccination and monitoring any adverse events or reactions.

What is being tested

7-valent Pneumococcal Conjugate Vaccine

+ 13-valent Pnumococcal Conjugate vaccine

+ 13-valent Pnumococcal Conjugate vaccine

Biological
Who is being recruted

Bacterial Infections and Mycoses+3

+ Bacterial Infections

+ Infections

+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorPfizer
Last updated: June 2, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

This clinical trial focuses on the prevention of pneumococcal diseases in healthy infants. It compares the safety, effectiveness, and immune system response of two vaccines: 13vPnC and 7vPnC. The study takes place in China and is important for understanding how well these vaccines protect infants from pneumococcal diseases, which can cause serious infections. The potential outcomes of this study could lead to improved care and protection for infants against these diseases. During the trial, infants receive either the 13vPnC or 7vPnC vaccine. The study measures the infants' immune response to the vaccines by testing their blood one month after vaccination. It also evaluates the safety of the vaccines by monitoring for any local reactions, systemic events, and adverse events. The study records the percentage of participants who experience these reactions or events. The results help determine which vaccine provides better protection and has fewer side effects for infants.

NCT01692886
Principal SponsorPfizer
Last updated: June 2, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1674 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bacterial Infections and MycosesBacterial InfectionsInfectionsStreptococcal InfectionsGram-Positive Bacterial InfectionsPneumococcal Infections

Criteria

2 inclusion criteria required to participate
Aged 42 to 77 days (approximately 2 months) at the time of enrollment
Healthy infant as determined by medical history, physical examination, and judgment of the investigator
3 exclusion criteria prevent from participating
A previous anaphylactic reaction to any vaccine or vaccine-related component
Contraindication to vaccination with pneumococcal vaccines
Previous vaccination with licensed or investigational pneumococcal vaccine

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator

Group II

Experimental

Group III

Experimental

Group IV

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Jiangsu Province Guanyun County Center for Disease prevention and Control

Guanyun County,, ChinaOpen Jiangsu Province Guanyun County Center for Disease prevention and Control in Google Maps

Jiangsu Province Huaiyin District Center for Disease prevention and Control

Huaian City,, China

Jiangsu Province Hongze County Center for Disease prevention and Control

Huaian City, China

Jiangsu Province Lianshui County Center for Disease prevention and Control

Lianshui County, China
Completed4 Study Centers