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

NCT01692886 | Completed Phase 3 DMC

• 2 other identifiers: B18510156096A1-3019
• Study Type: interventional
• Target: 1,674
• Locations: 1 country
• Sites: 4

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.

Conditions

Pneumococcal Infection

Keywords

13vPnC; 7vPnC; Healthy subjects; China

Outcome Measures

Primary Outcomes (10)

• 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 1 and Group 2.

  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 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 Outcomes (14)

• 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)

• 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)

Study Arms (4)

7vPnC (3-, 4-, 5-, 12-Month)

ACTIVE COMPARATOR

Biological: 7-valent Pneumococcal Conjugate Vaccine

13vPnC (3-, 4-, 5-, 12-Month)

EXPERIMENTAL

Biological: 13-valent Pnumococcal Conjugate vaccine

13vPnC (2-, 4-, 6-, 12-Month)

EXPERIMENTAL

Biological: 13-valent Pnumococcal Conjugate vaccine

13vPnC (3-, 5-, 12-Month)

EXPERIMENTAL

Biological: 13-valent Pnumococcal Conjugate vaccine

Interventions

7-valent Pneumococcal Conjugate Vaccine BIOLOGICAL

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

Also known as: 7vPnC

7vPnC (3-, 4-, 5-, 12-Month)

13-valent Pnumococcal Conjugate vaccine BIOLOGICAL

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

Also known as: 13vPnC

13vPnC (3-, 4-, 5-, 12-Month)

Eligibility Criteria

• Age: 42 Days - 77 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Jiangsu Province Guanyun County Center for Disease prevention and Control

Guanyun County,, Jiangsu, 222200, China

Location

Jiangsu Province Hongze County Center for Disease prevention and Control

Huaian City, Jiangsu, 223100, China

Location

Jiangsu Province Huaiyin District Center for Disease prevention and Control

Huaian City, Jiangsu, 223300, China

Location

Jiangsu Province Lianshui County Center for Disease prevention and Control

Lianshui County, Jiangsu, 223400, China

Location

Related Publications (2)

• Zhu F, Hu Y, Li J, Ye Q, Young MM Jr, Liang JZ, Gruber WC, Giardina PC, Scott DA. Immunogenicity and Safety of the 13-Valent Pneumococcal Conjugate Vaccine Administered in a 3 + 1 versus 2 + 1 Dose Schedule Among Infants in China. Pediatr Infect Dis J. 2019 Nov;38(11):1150-1158. doi: 10.1097/INF.0000000000002458.

  PMID: 31626050 DERIVED

• Zhu F, Hu Y, Li J, Ye Q, Young MM Jr, Zhou X, Chen Z, Yan B, Liang JZ, Gruber WC, Giardina PC, Scott DA. Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine Compared With 7-valent Pneumococcal Conjugate Vaccine Among Healthy Infants in China. Pediatr Infect Dis J. 2016 Sep;35(9):999-1010. doi: 10.1097/INF.0000000000001248.

  PMID: 27254028 DERIVED

Related Links

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

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: September 25, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 16, 2014

Record last verified: 2014-07

Locations

CN (4)