Effectiveness of an eleven-valent pneumococcal (type 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) conjugate vaccine against pneumonia in Philippine children: A double-blind, placebo-controlled, randomised, multicentre, effectiveness study

Completed

• Conditions: Pediatric pneumococcal pneumonia, sepsis, meningitis.; Respiratory; Pneumonia

• Registration Number: ISRCTN62323832
• Lead Sponsor: ARIVAC Consortium (Finland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-25
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12190

Inclusion Criteria

For the effectiveness study and the nested immunogenicity study:
1. Any child who comes for routine vaccination to a barangay health station in the 48 barangays in the six municipalities of Bohol, the Philippines (i.e. Baclayon, Balilihan, Cortes, Dauis, Panglao and Tagbilaran)
2. Considered to be in good health on the basis of medical history and observation taken at the barangay health station
3. At least 6 weeks of age and not older than 6 months of age
4. Having at least one parent or other legal representative giving their informed consent attested by signature

For the effectiveness study:
Is a resident of any of the barangays within the catchment of the 45 barangay health stations of the six municipalities for at least the past 3 months with his/her family, or intends to stay permanently

For the nested immunogenicity, safety and carriage study:
Is a resident of any of the barangays within the catchment of the three chosen barangay health stations (i.e. Dampas-Tagbilaran, Danao and Main Health Center-Panglao) for at least the past 3 months with his/her family, or intends to stay permanently

Exclusion Criteria

For the effectiveness study and the nested immunogenicity study:
Any child who:
1. Has received the first dose of diphtheria, tetanus, pertussis (DTP) vaccine
2. Has acute febrile illness (rectal temperature >/= 38.5°C) at the time of inclusion
3. Is suspected to have a neurological disease (a contraindication to the DTP vaccine)
4. Has history of hospitalization for and/or treatment for immune suppression
5. Is enrolled or scheduled to be enrolled in another clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiologically confirmed, community-acquired pneumonia at least 14 days after the third dose of the study vaccine in first 2 years of life.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes: World Health Organisation (WHO) Pneumonia<br>1.1. Any episode of community-acquired pneumonia requiring or not requiring hospitalization<br>1.2. Any episode of community-acquired pneumonia requiring hospitalization<br>2. Any episode of community-acquired pneumonia not requiring hospitalization<br>3. Any episode of culture proven invasive pneumococcal disease, determined as vaccine-specific serotype, vaccine-related serotype, vaccine serogroup, or non-vaccine serotype or group of Streptococcus pneumoniae<br>4. Safety of the 11PCV when administered concomitantly with the EPI and Hib vaccines<br>5. Reactogenicity of the 11PCV after each injection<br>6. Immunogenicity and the opsonophagocytic activity (OPA) of the 11PCV in 11PCV and placebo recipients<br>7. Nasopharyngeal carriage of vaccine and non-vaccine specific serotypes of Streptococcus pneumoniae in 11PCV and placebo recipients