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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
ISRCTN ISRCTN62323832
DOI 10.1186/ISRCTN62323832
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title
Acronym ARIVAC
Serial number at source PNF13399
Study hypothesis Primary objective: The vaccine is efficacious in preventing community-acquired X-ray positive pneumonia. The minimum efficacy, estimated by the lower limit of the 95% confidence interval, is 15%. The relative risk of the X-ray positive pneumonia in the vaccine group is less than 0.85 when compared to the placebo group.

Objective 2a: Hypothesis: The vaccine is efficacious in preventing community-acquired pneumonia requiring hospitalization. The relative risk of pneumonia is lower than one when compared to the placebo group; in other words, the vaccine efficacy is higher than 0%.

Objective 2b: Hypothesis: The vaccine is efficacious in preventing community-acquired pneumonia not requiring hospitalization. The relative risk of pneumonia is lower than one when compared to the placebo group; in other words, the vaccine efficacy is higher than 0%.

Objective 2c: Hypothesis: The vaccine is efficacious in preventing culture proven vaccine type-specific invasive pneumococcal disease. The relative risk of culture proven vaccine type-specific invasive pneumococcal disease is lower than one when compared to the placebo group; in other words, the vaccine efficacy is higher than 0%.

Objective 2d: Hypothesis: The eleven-valent pneumococcal conjugate vaccine is safe when administered concomitantly with the vaccines of Expanded Programmes on Immunization (EPI) and Hib vaccine.

For the nested carriage and immunogenicity study:
Objective 2e: Hypothesis: Children immunized with the eleven-valent pneumococcal vaccine have higher concentrations of antipneumococcal polysaccharide antibodies and higher opsonophagocytic activity in comparison to the placebo recipients.

Objective 2f: Hypothesis: Significantly fewer children immunized with the eleven-valent pneumococcal conjugate vaccine will carry vaccine serotypes of Streptococcus pneumoniae than the placebo recipients.
Lay summary Not provided at time of registration
Ethics approval The Technical Review Board and Ethical Review Board (Institutional Review Board [IRB]) of the Research Institute for Tropical Medicine (RITM), Philippines, reviewed and approved the original study protocol in 1999. A counterpart ethical review committee at the National Public Health Institute in Finland likewise reviewed the study protocol, and approved it in the same year. The RITM IRB evaluated yearly the progress of the study and gave its corresponding approval to proceed with the conduct of the trial. The latest approval was awarded on August 8, 2005.
Study design Randomised controlled trial
Countries of recruitment Philippines
Disease/condition/study domain Pediatric pneumococcal pneumonia, sepsis, meningitis.
Participants - 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
Participants - 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
Anticipated start date 05/07/2000
Anticipated end date 18/12/2004
Status of trial Completed
Patient information material
Target number of participants 12,190
Interventions Study Vaccine Group: An eleven-valent pneumococcal tetanus-diphtheria toxoid conjugated vaccine, diphtheria-tetanus-pertussis whole cell vaccine, Haemophilus influenzae type b vaccine, hepatitis B vaccine, oral polio vaccine, measles vaccine according to national immunization program schedule.

Control (Placebo) Vaccine Group: Saline (NaCl), diphtheria-tetanus-pertussis whole cell vaccine, Haemophilus influenzae type b vaccine, hepatitis B vaccine, oral polio vaccine, measles vaccine according to national immunization program.
Primary outcome measure(s) 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 measure(s) Secondary outcomes: World Health Organisation (WHO) Pneumonia
1.1. Any episode of community-acquired pneumonia requiring or not requiring hospitalization
1.2. Any episode of community-acquired pneumonia requiring hospitalization
2. Any episode of community-acquired pneumonia not requiring hospitalization
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
4. Safety of the 11PCV when administered concomitantly with the EPI and Hib vaccines
5. Reactogenicity of the 11PCV after each injection
6. Immunogenicity and the opsonophagocytic activity (OPA) of the 11PCV in 11PCV and placebo recipients
7. Nasopharyngeal carriage of vaccine and non-vaccine specific serotypes of Streptococcus pneumoniae in 11PCV and placebo recipients
Sources of funding 1. National Health and Medical Research Council (NHMRC) (Australia)
2. European Commission (Belgium) - DG Research, INCO Programme
3. Finnish Academy (Finland)
4. Finnish Ministry of Foreign Affairs (Finland)
5. Physicians for Social Responsibility (PSR) (Finland)
6. Program for Appropriate Technology and Health (PATH) (USA)
7. Global Alliance for Vaccines, Accelerated Development and Implementation Plan (GAVI ADIP Pnc) (Switzerland)
8. Provincial Government of Bohol (Philippines)
9. Local government units of Tagbilaran City, Dauis, Panglao, Balilihan, Cortez and Baclayon (Philippines)
10. Research Institute for Tropical Medicine (RITM) (Philippines)
11. National Public Health Institute (KTL) (Finland)
12. University of Colorado (USA)
13. University of Queensland (Australia)
14. Sanofi Pasteur (France)
Trial website http://hisdu2.sph.uq.edu.au/arivac/
Publications 1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18644109
2. 2012 evaluation in http://www.ncbi.nlm.nih.gov/pubmed/22676626
Contact name Dr  Marilla  Lucero
  Address Research Institute for Tropical Medicine (RITM)
Research Drive
Filinvest Corporate City
Alabang
  City/town Muntinlupa City
  Zip/Postcode 1781
  Country Philippines
  Tel +63 (0)2 807 2634
  Fax +63 (0)2 807 2634
  Email mglucero@pldtdsl.net
Sponsor ARIVAC Consortium (Finland)
  Address National Public Health Institute (Kansanterveyslaitos)
Mannerheimintie 166
  City/town Helsinki
  Zip/Postcode 00300
  Country Finland
  Tel +358 (0)947 448749
  Fax +358 (0)947 448675
  Email hanna.nohynek@ktl.fi
  Sponsor website: http://www.sph.uq.edu.au/arivac
Date applied 13/09/2005
Last edited 05/11/2012
Date ISRCTN assigned 25/01/2006
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