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

NCT ID: NCT00366340

Last Updated: 2012-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 604 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-08-31

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 7-valent pneumococcal conjugate (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3, 4, months (infant series) and at 11-12 months of age (toddler dose) in Germany.

Conditions

Vaccines, Pneumococcal

Keywords

safety; Vaccine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1

13-valent pneumococcal conjugate vaccine

Group Type: EXPERIMENTAL

13-valent pneumococcal conjugate vaccine

Intervention Type: BIOLOGICAL

Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age

2

7-valent pneumococcal conjugate vaccine

Group Type: ACTIVE_COMPARATOR

7-valent pneumococcal conjugate vaccine

Intervention Type: BIOLOGICAL

Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age

Interventions

13-valent pneumococcal conjugate vaccine

Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age

Intervention Type: BIOLOGICAL

7-valent pneumococcal conjugate vaccine

Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Aged 2 months (56 to 112 days) at time of enrollment.

2. Available for entire study period and whose parent(s) or legal guardian(s) could be reached by telephone.

3. Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.

4. Parent(s) or legal guardian(s) had to be able to complete all relevant study procedures during study participation.

Exclusion Criteria

1. Previous vaccination with licensed or investigational pneumococcal vaccine.

2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B vaccines.

3. A previous anaphylactic reaction to any vaccine or vaccine-related component.

4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B, or pneumococcal vaccines.

5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.

6. Known or suspected immune deficiency or suppression.

7. History of culture-proven invasive disease caused by S pneumoniae or H influenzae type b.

8. Major known congenital malformation or serious chronic disorder.

9. 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. Did not include resolving syndromes due to birth trauma such as Erb palsy.

10. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).

11. Participation in another investigational trial. Participation in purely observational studies was acceptable.

12. Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.

• Minimum Eligible Age: 56 Days
• Maximum Eligible Age: 112 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Germany, medinfoDEU@wyeth.com

Locations

Bad Kreuznach, , Germany

Bad Saulgau, , Germany

Bad Sobernheim, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Birkenfeld, , Germany

Bobingen, , Germany

Bramsche, , Germany

Bretten, , Germany

Cham, , Germany

Ehingen, , Germany

Erlangen, , Germany

Eschwege, , Germany

Flensburg, , Germany

Gau-Odernheim, , Germany

Hamburg, , Germany

Herzogenaurach, , Germany

Höchberg, , Germany

Kehl, , Germany

Kiel, , Germany

Kleve, , Germany

Krefeld, , Germany

Ludwigshafen, , Germany

Lübeck, , Germany

Mainz, , Germany

Metzingen, , Germany

Minden, , Germany

Münster, , Germany

Münster, , Germany

Neumünster, , Germany

Neumünster, , Germany

Neustadt/Aisch, , Germany

Niebüll, , Germany

Nuremberg, , Germany

Nuremberg, , Germany

Oberkirch, , Germany

Olching, , Germany

Pforzheim, , Germany

Porta Westfalica, , Germany

Ravensburg, , Germany

Tettnang, , Germany

Vellmar, , Germany

Weiden, , Germany

Weilheim, , Germany

Welzheim, , Germany

Wiesbaden, , Germany

Zirndorf, , Germany

Countries

Germany

References

Gimenez-Sanchez F, Kieninger DM, Kueper K, Martinon-Torres F, Bernaola E, Diez-Domingo J, Steul K, Juergens C, Gurtman A, Giardina P, Liang JZ, Gruber WC, Emini EA, Scott DA; 501 and 006 study groups. Immunogenicity of a combination vaccine containing diphtheria toxoid, tetanus toxoid, three-component acellular pertussis, hepatitis B, inactivated polio virus, and Haemophilus influenzae type b when given concomitantly with 13-valent pneumococcal conjugate vaccine. Vaccine. 2011 Aug 11;29(35):6042-8. doi: 10.1016/j.vaccine.2011.06.026. Epub 2011 Jun 23.

Reference Type: DERIVED

PMID: 21704105 (View on PubMed)

Other Identifiers

6096A1-006

Identifier Type: -

Identifier Source: org_study_id