Clinical trial NCT00366340: Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
Official title: A Phase 3, Randomized, Active-Controlled, Double-blind Trial of the Safety, Tolerability, and Immunologic Non-Inferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Germany.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaccines, Pneumococcal
Keywords: safety
Vaccine
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-21
Enrollment: 604
Sex: ALL
Minimum age (years): 56
Maximum age (years): 112
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
timeFrame: One month after 3-dose infant series (5 months of age)
measure: Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
timeFrame: One month after 3-dose infant series (5 months of age)
measure: Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.
timeFrame: One month after 3-dose infant series (5 months of age)
measure: Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
timeFrame: One month after 3-dose infant series (5 months of age)
measure: Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
timeFrame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
measure: Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
timeFrame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
measure: Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
timeFrame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
measure: Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
timeFrame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
measure: Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
timeFrame: Immediately before (12 months of age) and one month after the toddler dose (13 months of age)
measure: Percentage of Participants Reporting Pre-Specified Local Reactions
timeFrame: Day 1 through 4 after each dose
measure: Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
timeFrame: Day 1 through 4 after each dose
measure: Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
timeFrame: Day 1 through 4 after each dose
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Kreuznach
country: Germany
city: Bad Saulgau
country: Germany
city: Bad Sobernheim
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Birkenfeld
country: Germany
city: Bobingen
country: Germany
city: Bramsche
country: Germany
city: Bretten
country: Germany
city: Cham
country: Germany
city: Ehingen
country: Germany
city: Erlangen
country: Germany
city: Eschwege
country: Germany
city: Flensburg
country: Germany
city: Gau-Odernheim
country: Germany
city: Hamburg
country: Germany
city: Herzogenaurach
country: Germany
city: Hoechberg
country: Germany
city: Kehl
country: Germany
city: Kiel
country: Germany
city: Kleve
country: Germany
city: Krefeld
country: Germany
city: Ludwigshafen
country: Germany
city: Luebeck
country: Germany
city: Mainz
country: Germany
city: Metzingen
country: Germany
city: Minden
country: Germany
city: Muenster
country: Germany
city: Muenster
country: Germany
city: Neumuenster
country: Germany
city: NeumÃ¼nster
country: Germany
city: Neustadt/Aisch
country: Germany
city: Niebuell
country: Germany
city: Nuernberg
country: Germany
city: Nuernberg
country: Germany
city: Oberkirch
country: Germany
city: Olching
country: Germany
city: Pforzheim
country: Germany
city: Porta Westfalica
country: Germany
city: Ravensburg
country: Germany
city: Tettnang
country: Germany
city: Vellmar
country: Germany
city: Weiden
country: Germany
city: Weilheim
country: Germany
city: Welzheim
country: Germany
city: Wiesbaden
country: Germany
city: Zirndorf
country: Germany
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Germany, medinfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.