Clinical trial NCT00708682: Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico
Official title: A Phase 3, Open Label, Single Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Mexico
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaccines, Pneumococcal
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-02
Enrollment: 225
Sex: ALL
Minimum age (years): 42
Maximum age (years): 98
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study will be to evaluate safety, tolerability and immunogenicity of 13-valent pneumococcal vaccine in healthy infants given with routine pediatric vaccinations in Mexico.


Eligibility criteria: Inclusion Criteria:

* Healthy 2 month infants, available for entire study period and parent/legal guardian reachable by telephone
* Able to complete three blood draws during study
* At least 3.5 kg at enrollment

Exclusion Criteria:

* Previous vaccination (except Hepatitis, BCG), contraindication or allergic reaction to vaccines
* Immune deficiency, bleeding disorder or significant chronic medical condition

Primary outcomes:
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series
timeFrame: 1 month after the infant series (7 months of age)
Secondary outcomes:
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series
timeFrame: 1 month after dose 2 of the infant series (5 months of age)
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose (13 months of age)
Other outcomes:
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series
timeFrame: Dose 2 of infant series (4 months of age)
measure: GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series
timeFrame: Dose 3 of infant series (6 months of age)
measure: GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose
timeFrame: Toddler Dose (12 months of age)
measure: Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)
timeFrame: Within 4 days after dose 1 of Infant Series (2 months of age)
measure: Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)
timeFrame: Within 4 days after dose 2 of Infant Series (4 months of age)
measure: Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)
timeFrame: Within 4 days after dose 3 (6 months of age)
measure: Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
timeFrame: Within 4 days after toddler dose (12 months of age)
measure: Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age)
timeFrame: Within 4 days after dose 1 of Infant Series (2 months of age)
measure: Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age)
timeFrame: Within 4 days after dose 2 of Infant Series (4 months of age)
measure: Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age)
timeFrame: Within 4 days after dose 3 of Infant Series (6 months of age)
measure: Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age)
timeFrame: Within 4 days after toddler dose (12 months of age)
Locations:
city: Guadalajara
country: Mexico
state: Jalisco
city: Morelia
country: Mexico
state: Michoacan
city: Cuernavaca
country: Mexico
state: Morelos
city: Monterrey
country: Mexico
state: Nuevo Leon
city: Merida
country: Mexico
state: Yucatan
city: Distrio Federal
country: Mexico
city: Distrio Federal
country: Mexico
city: Oaxaca
country: Mexico
city: Puebla
country: Mexico
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.