Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

NCT00384059 | Completed Phase 3 Results

• 1 other identifier: 6096A1-007
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccines in the United Kingdom.

Conditions

Vaccines, Pneumococcal

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.

  Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥1:8 and predefined antibody threshold levels with the corresponding 95% CI for concomitant antigens polyribosylribitol phosphate (PRP) in haemophilus influenzae type b \[Hib\](≥0.15 μg/mL or ≥ 1.0 μg/mL), pertussis toxoid \[PT\], filamentous haemagglutinin, pertactin \[FHA\], and pertactin (PRN) (≥5 Elisa Units EU/mL) and fimbrial agglutinogens \[FIM\] (≥2.2 EU/mL) are presented.

  One month after infant series dose 2 (5 months of age)

• Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series

  one month after infant series dose 2 (5 months of age)

• Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series

  one month after infant series dose 2 (5 months of age)

• Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series

  one month after infant series dose 2 (5 months of age)

• Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose

  Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% 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.

  one month after infant series dose 2 (5 months of age), before and after toddler dose (12 months of age)

• Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.

  Antibody concentration/geometric mean concentration (GMC) as measured by ELISA for 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 with corresponding 2-sided 95% CI.

  one month after infant series dose 2 (5 months of age) and before and after toddler dose (12 months of age)

Secondary Outcomes (4)

• Percentage of Participants Achieving an SBA Titer ≥1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose.

  one month after the toddler dose (13 months of age)

• Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose.

  one month after toddler dose (13 months of age)

• Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose.

  one month after toddler dose (13 months of age)

• Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose

  one month after toddler dose (13 months of age)

Other Outcomes (2)

• Percentage of Participants Reporting Pre-Specified Local Reactions

  During the 4-day period after each dose

• Percentage of Participants Reporting Pre-Specified Systemic Events

  During the 4-day period after each dose

Study Arms (2)

1

EXPERIMENTAL

13-valent pneumococcal vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine; Biological: Pediacel; Biological: NeisVac-C; Biological: Menitorix

2

ACTIVE COMPARATOR

7-valent pneumococcal vaccine

Biological: 7vPnC; Biological: Pediacel; Biological: NeisVac-C; Biological: Menitorix

Interventions

13-valent Pneumococcal Conjugate Vaccine BIOLOGICAL

Single 0.5 mL dose given at 2, 3, 4, and 12 months of age

1

7vPnC BIOLOGICAL

Single 0.5 mL dose given at 2, 3, 4 and 12 months of age

2

Pediacel BIOLOGICAL

concommitant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age

1; 2

NeisVac-C BIOLOGICAL

concomittant vaccine, both at arm 1 and at arm 2, at 2 months and 4 months of age

1; 2

Menitorix BIOLOGICAL

concomitant vaccine, both at arm 1 and at arm 2, at 12 months of age

1; 2

Eligibility Criteria

• Age: 42 Days - 98 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged 2 months (42 to 98 days) at the time of enrollment.
• Available for entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
• Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
• Parent(s)/legal guardian(s) had to be able to complete all relevant study procedures during study participation.

You may not qualify if:

• Previous vaccination with licensed or investigational pneumococcal vaccine.
• Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or meningococcal vaccines.
• A previous anaphylactic reaction to any vaccine or vaccine-related component.
• Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, pneumococcal conjugate, or meningococcal conjugate vaccines.
• Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
• Known or suspected immune deficiency or suppression.
• History of culture-proven invasive disease caused by S pneumoniae, Neisseria meningitidis, or Hib.
• Major known congenital malformation or serious chronic disorder.
• Significant neurological disorder or history of seizure, including febrile seizure, or significant stable or evolving disorders, such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. This did not include resolving syndromes due to birth trauma such as Erb palsy.
• Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
• Participation in another investigational trial. Participation in purely observational studies was acceptable.
• Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (11)

Unknown Facility

Atherstone, CV9 1EU, United Kingdom

Location

Unknown Facility

Bangor, BT19 1NB, United Kingdom

Location

Unknown Facility

Bristol, BS2 8AE, United Kingdom

Location

Unknown Facility

Co Antrim, BT41 3AE, United Kingdom

Location

Unknown Facility

Coventry, CV6 4DD, United Kingdom

Location

Unknown Facility

Ely, CB7 4HF, United Kingdom

Location

Unknown Facility

London, SW17 ORE, United Kingdom

Location

Unknown Facility

Oxford, OX3 9DU, United Kingdom

Location

Unknown Facility

Plymouth, PL5 3JB, United Kingdom

Location

Unknown Facility

Southampton, SO16 6YD, United Kingdom

Location

Unknown Facility

Weston-super-Mare, BS22 6AJ, United Kingdom

Location

Related Publications (2)

• Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.

  PMID: 23965217 DERIVED

• Snape MD, Klinger CL, Daniels ED, John TM, Layton H, Rollinson L, Pestridge S, Dymond S, Galiza E, Tansey S, Scott DA, Baker SA, Jones TR, Yu LM, Gruber WC, Emini EA, Faust SN, Finn A, Heath PT, Pollard AJ. Immunogenicity and reactogenicity of a 13-valent-pneumococcal conjugate vaccine administered at 2, 4, and 12 months of age: a double-blind randomized active-controlled trial. Pediatr Infect Dis J. 2010 Dec;29(12):e80-90. doi: 10.1097/inf.0b013e3181faa6be.

  PMID: 21155091 DERIVED

MeSH Terms

Interventions

diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine

Results Point of Contact

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

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For UK/Great Britian, ukmedinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

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: October 2, 2006
• First Posted: October 4, 2006
• Study Start: October 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: January 24, 2013
• Results First Posted: August 15, 2012

Record last verified: 2013-01

Locations

GB (11)