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 | https://doi.org/10.1186/ISRCTN62323832 |
| Secondary identifying numbers | PNF13399 |
- Submission date
- 13/09/2005
- Registration date
- 25/01/2006
- Last edited
- 05/11/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Marilla Lucero
Scientific
Scientific
Research Institute for Tropical Medicine (RITM)
Research Drive
Filinvest Corporate City
Alabang
Muntinlupa City
1781
Philippines
| Phone | +63 (0)2 807 2634 |
|---|---|
| mglucero@pldtdsl.net |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Scientific title | |
| Study acronym | ARIVAC |
| 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. |
| Ethics approval(s) | 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. |
| Condition | Pediatric pneumococcal pneumonia, sepsis, meningitis. |
| Intervention | 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. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 | 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 |
| Overall study start date | 05/07/2000 |
| Overall study end date | 18/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Weeks |
| Upper age limit | 6 Months |
| Sex | Both |
| Target number of participants | 12,190 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 05/07/2000 |
| Recruitment end date | 18/12/2004 |
Locations
Countries of recruitment
- Philippines
Study participating centre
Research Institute for Tropical Medicine (RITM)
Muntinlupa City
1781
Philippines
1781
Philippines
Sponsor information
ARIVAC Consortium (Finland)
Other
Other
National Public Health Institute (Kansanterveyslaitos)
Mannerheimintie 166
Helsinki
00300
Finland
| Phone | +358 (0)947 448749 |
|---|---|
| hanna.nohynek@ktl.fi | |
| Website | http://www.sph.uq.edu.au/arivac |
Funders
Funder type
Other
National Health and Medical Research Council (NHMRC) (Australia)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NHMRC
- Location
- Australia
European Commission (Belgium) - DG Research, INCO Programme
No information available
Finnish Academy (Finland)
No information available
Finnish Ministry of Foreign Affairs (Finland)
No information available
Physicians for Social Responsibility (PSR) (Finland)
No information available
Program for Appropriate Technology and Health (PATH) (USA)
No information available
Global Alliance for Vaccines, Accelerated Development and Implementation Plan (GAVI ADIP Pnc) (Switzerland)
No information available
Provincial Government of Bohol (Philippines)
No information available
Local government units of Tagbilaran City, Dauis, Panglao, Balilihan, Cortez and Baclayon (Philippines)
No information available
Research Institute for Tropical Medicine (RITM) (Philippines)
No information available
National Public Health Institute (KTL) (Finland)
No information available
University of Colorado (USA)
No information available
University of Queensland (Australia)
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Queensland in Australia, University of Queensland - Australia, The University of Queensland | Brisbane QLD, uniofqld, The University of Queensland, UQ
- Location
- Australia
Sanofi Pasteur (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/07/2008 | Yes | No | |
| Other publications | evaluation | 07/06/2012 | Yes | No |
