A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China

A Phase 3, Randomized, Active-controlled Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13vPnC Vaccine Compared With a 7vPnC in Healthy Infants in China

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01692886

Enrollment

1674

Registered

2012-09-25

Start date

2012-08-31

Completion date

2014-04-30

Last updated

2014-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Infection

Keywords

13vPnC, 7vPnC, Healthy subjects, China

Brief summary

This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when measured 1 month after the infant series, and to evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events and adverse events.

Interventions

BIOLOGICAL7-valent Pneumococcal Conjugate Vaccine

suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively

BIOLOGICAL13-valent Pnumococcal Conjugate vaccine

suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

42 Days to 77 Days

Healthy volunteers

Yes

Inclusion criteria

1. Aged 42 to 77 days (approximately 2 months) at the time of enrollment. 2. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.

Exclusion criteria

1. Previous vaccination with licensed or investigational pneumococcal vaccine. 2. A previous anaphylactic reaction to any vaccine or vaccine-related component. 3. Contraindication to vaccination with pneumococcal vaccines.

Design outcomes

Primary

Measure	Time frame
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 1 and Group 2.	1 month after the infant series (6 Months of age)
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 1 And Group 2.	1 month after the infant series (6 Months of age)
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 3.	1 month after the infant series (7 Months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 3.	1 month after the infant series (7 Months of age)
Percentage of Participants Reporting Adverse Events in Group 1 and Group 2.	Approximately 16 months from the participation into the study to the end of study
Percentage of Participants Reporting Adverse Events in Group 3 and Group 4.	Approximately 16 months from the participation into study to the end of study
Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2.	Seven days after each pneumococcal vaccination dose within the period up to 12 months
Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4.	Seven days after each pneumococcal vaccination dose within the period up to 12 months
Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2.	Seven days after each pneumococcal vaccination dose within the period up to 12 months
Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4.	Seven days after each pneumococcal vaccination dose within the period up to 12 months

Secondary

Measure	Time frame
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 4.	1 month after the infant series (6 Months of age)
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 4.	1 month after the toddler dose (13 Months of age)
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 1 And Group 2.	1 month after the infant series (6 Months of age)
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 4.	1 month after the toddler dose (13 Months of age)
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 4.	1 month after the infant series (6 Months of age)
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 3.	1 month after the infant series (7 Months of age)
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 1 and Group 2.	1 month after the infant series (6 Months of age)
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 3.	1 month after the infant series (7 Months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 2 and Group 3.	1 month after the toddler dose (13 Months of age)
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 2 and Group 3.	1 month after the toddler dose (13 Months of age)
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 2 and Group 3.	1 month after the toddler dose (13 Months of age)
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 4.	1 month after the infant series (6 Months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 4.	1 month after the infant series (6 Months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 4.	1 month after the toddler dose (13 Months of age)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026