Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants

NCT01200368 | Completed Phase 3 Results

• 2 other identifiers: B18510566096A1-3024
• Study Type: interventional
• Target: 551
• Locations: 1 country
• Sites: 32

Brief Summary

Subjects will be randomly assigned to 1 of 3 groups to receive the following vaccines: Group 1: 13-valent pneumococcal conjugate vaccine (13vPnC) and diphtheria, tetanus, and acellular pertussis vaccine (DTaP), Group 2: 7-valent pneumococcal conjugate vaccine (7vPnC) and DTaP, Group 3: DTaP alone. Group 3 subjects will also receive catch-up doses of Prevenar (commercial product of Prevenar in Japan) 13vPnC and 7vPnC will be blinded, and DTaP will be open-label. The main purpose of the study is to determine if the immune responses to 13vPnC are comparable to the immune responses to 7vPnC and if the immune responses to 13vPnC given with DTaP are comparable to those induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 13vPnC and 7vPnC when given with DTaP in healthy Japanese infants.

Conditions

Healthy Subjects

Keywords

vaccine; pneumococcal conjugate

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series

  Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.

  1 month after the infant series

• Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series

  Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.

  1 month after the infant series

• Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series

  Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).

  1 month after the infant series

Secondary Outcomes (8)

• Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series

  1 month after the infant series

• Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose

  1 month after the toddler dose

• Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose

  1 month after the toddler dose

• Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose

  1 month after the toddler dose

• Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series

  1 month after the infant series

Other Outcomes (8)

• Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)

  Within 7 days after Dose 1 of the infant series

• Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)

  Within 7 days after Dose 2 of the infant series

• Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)

  Within 7 days after Dose 3 of the infant series

Study Arms (3)

1

EXPERIMENTAL

Experimental

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)

2

ACTIVE COMPARATOR

Active comparator

Biological: 7-valent pneumococcal conjugate vaccine (7vPnC); Biological: DTaP

3

ACTIVE COMPARATOR

Active comparator

Biological: DTaP

Interventions

13-valent pneumococcal conjugate vaccine (13vPnC) BIOLOGICAL

0.5 mL per dose, 4 doses

1

diphtheria, tetanus, and acellular pertussis vaccine (DTaP) BIOLOGICAL

0.5 mL per dose, 4 doses

1

7-valent pneumococcal conjugate vaccine (7vPnC) BIOLOGICAL

0.5 mL per dose, 4 doses

2

DTaP BIOLOGICAL

0.5 mL per dose, 4 doses

2

Eligibility Criteria

• Age: 3 Months - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female subjects between 3 to 6 months of age at the enrollment.
• Available for the entire study period and whose parent/legal guardian can be reached by telephone.
• Healthy infant as determined by medical history, physical examination, and judgement of the investigator.

You may not qualify if:

• Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, or pertussis vaccines.
• A previous anaphylactic reaction to any vaccine or vaccine-related component.
• Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
• History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis, bacteremia, osteomyelitis, arthritis).
• Infant who is a direct descendant (child, grandchild) of the study site personnel.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (32)

Sunrise Children's Clinic

Funabashi, Chiba, 273-0035, Japan

Location

Sotobo Children's Clinic

Isumi, Chiba, 299-4503, Japan

Location

Matsuyama Red Cross Hospital

Matsuyama, Ehime, 790-8524, Japan

Location

Fukazawa Pediatric Clinic

Higashi-ku, Fukuoka-city, Fukuoka, 813-0036, Japan

Location

National Hospital Organization Fukuyama Medical Center

Fukuyama, Hiroshima, 720-8520, Japan

Location

National Hospital Organization Kure Medical Center

Kure, Hiroshima, 737-0023, Japan

Location

Nakata pediatric clinic

Sapporo, Hokkaido, 003-0023, Japan

Location

Watanabe Pediatric Allergy Clinic

Sapporo, Hokkaido, 006-0831, Japan

Location

Furuta Children's Clinic

Sapporo, Hokkaido, 063-0831, Japan

Location

Motomachi pediatric clinic

Sapporo, Hokkaido, 065-0024, Japan

Location

Tenshi Hospital

Sapporo, Hokkaido, 065-8611, Japan

Location

Yoshimoto Pediatrist Clinic

Kikuchi-gun, Kumamoto, 869-1102, Japan

Location

Shiroko Clinic

Suzuka, Mie-ken, 510-0235, Japan

Location

National Mie Hospital

Tsu, Mie-ken, 514-0125, Japan

Location

National hospital Organization Mie Chuou Medical Center

Tsu, Mie-ken, 514-1101, Japan

Location

Children's Enomoto Clinic

Kumagaya, Saitama, 360-0018, Japan

Location

Shibuya Clinic

Kumagaya, Saitama, 360-0812, Japan

Location

Sakiyama Children's Clinic

Fuchū, Tokyo, 183-0042, Japan

Location

Okawa Children and Family Clinic

Ōta-ku, Tokyo, 146-0095, Japan

Location

Seijo Sasamoto Pediatric And Allergy Clinic

Setagaya-ku, Tokyo, 157-0066, Japan

Location

National Center for Child Health and Development

Setagaya-ku, Tokyo, 157-8535, Japan

Location

Miyata Pediatric Clinic

Tachikawa-shi, Tokyo, 190-0002, Japan

Location

Maehara Pediatric Clinic

Tama, Tokyo, 206-0011, Japan

Location

Childrens Clinic of Kose

Kofu, Yamanashi, 400-0853, Japan

Location

Medical Corporation Bunpoukai Amemiya Clinic

Koushu-shi, Yamanashi, 404-0046, Japan

Location

Medical Corporation Seijinkai Takei Clinic

Tsuru-shi, Yamanashi, 402-0025, Japan

Location

National Hospital Organization Fukuoka National Hospital

Fukuoka, 811-1394, Japan

Location

Harada Clinic

Fukuoka, 816-0094, Japan

Location

Hattori Pediatric Clinic

Kumamoto, 860-0812, Japan

Location

Medical Corporation Seiaikai Seguchi Pediatric Clinic

Kumamoto, 860-0834, Japan

Location

Medical Corporation Oukakai Sakuranbo Kodomo Clinic

Kumamoto, 862-0924, Japan

Location

Momotaro Clinic

Okayama, 701-0205, Japan

Location

Related Publications (1)

• Togashi T, Okada K, Yamaji M, Thompson A, Gurtman A, Cutler M, Aizawa M, Gruber WC, Scott DA. Immunogenicity and Safety of a 13-Valent Pneumococcal Conjugate Vaccine Given With DTaP Vaccine in Healthy Infants in Japan. Pediatr Infect Dis J. 2015 Oct;34(10):1096-104. doi: 10.1097/INF.0000000000000819.

  PMID: 26121200 DERIVED

MeSH Terms

Interventions

Diphtheria-Tetanus-acellular Pertussis Vaccines; Heptavalent Pneumococcal Conjugate Vaccine

Intervention Hierarchy (Ancestors)

Pertussis Vaccine; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit; Pneumococcal Vaccines; Streptococcal Vaccines

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 13, 2010
• Study Start: September 24, 2010
• Primary Completion: November 30, 2011
• Study Completion: November 30, 2011
• Last Updated: December 19, 2018
• Results First Posted: October 12, 2012

Record last verified: 2018-11

Locations

JP (32)