Evaluation of alternative vaccination schedules for Pneumococcal Conjugate Vaccine (PCV) (Philippines)
| ISRCTN | ISRCTN63282459 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63282459 |
| Secondary identifying numbers | WHO/RPC032 |
- Submission date
- 04/08/2004
- Registration date
- 22/09/2004
- Last edited
- 06/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Marilla Lucero
Scientific
Scientific
Research Institute for Tropical Medicine
Filinvest Corporate City
Alabang
Muntinlupa City
1781
Philippines
| mglucero@pldtdsl.net |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | |
| Study objectives | This study proposes evaluation of immunogenicity and safety of 1 to 3 doses of PCV or alternatively one or two doses of PCV. The vaccines are given within the schedule of the Expanded Programme on Immunisation (EPI) of 6, 10, and 14 weeks common in many developing countries. The proposed age for the first immunisation with PCV is 6 weeks of age, which has the highest coverage and best timeliness in most national programmes. Both PCV and PPS vaccines have been used as a booster following the primary series with PCV. The PPS vaccine with higher PS content (25 mcg vs. 2-10 mcg ) may induce higher GMCs than PCV vaccines, but the avidity of antibodies might be higher following a booster dose of PCV. The results of this study together with information on disease burden estimates and cost-effectiveness analyses could play an important part in the decision-making process or whether or not to include the PCV in the national immunization program. Objectives: The primary objective of this study is to compare immune responses following the primary series of one or two doses of PCV to the reference group receiving three doses of PCV when measured at 18 weeks of age. The secondary objectives are: 1. To describe the peak antibody responses one month after 1, 2 or 3 doses of PCV in early infancy 2. To compare the development of immunological memory by the 3 different immunisation schedules with PCV 3. To assess the immune response to serotypes 1 and 5 present in the PPS but not in the PCV in infants receiving PPS at 9 months of age 4. To describe persistence of serotype specific anti-pneumococcal PS antibodies following three different primary series schedules when measured at 9 months of age 5. To confirm the functional activity of the elicited antibodies by evaluating the opsonophagocytic activity of the antibodies in a randomly selected sub-set of 30 serum samples taken at 18 weeks and 7 days after the vaccinations at 9 months in each of the four study arms 6. To describe safety and tolerability of PCV administered according to the different immunisation schedules (combined active and passive surveillance) 7. To describe the immunogenicity of concomitant vaccine antigens (DT, HBV, Hib) at 18 weeks of age in order to rule out interference caused by PCV |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pneumococcus/vaccines |
| Intervention | The study is a multi-centre, individual-randomised, open, proof of principle phase II trial to be carried out in Cabuyao, the Philippines with 4 arms. The study groups will receive 1, 2 or 3 doses of 7-valent pneumococcal conjugate vaccine (PCV), reference group will receive the standard 3-dose schedule of PCV and the control group no pneumococcal vaccines except at the exit from study. The effect of boosting at 9 months of age with pneumococcal polysaccharide vaccine after one or two doses of PCV on the antibody concentrations and B cell memory will be studied as well as the possible induction of hyporesponsiveness. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Pneumococcal conjugate vaccine |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/05/2005 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 900 |
| Key inclusion criteria | Children who: 1. Are considered to be in good health on the basis of medical history and physical examination 2. Born at full term of pregnancy (≥37 weeks) 3. Are at least 6 weeks (max 9 weeks) of age when starting the Diphtheria, Tetanus, Pertussis (DTP) 4. Whose parents have lived in the study area at least 3 months and have no intention to move out of the area during the next 9 months 5. For whom at least one of the parents or other legally acceptable representative has given his/her informed consent attested by a signature |
| Key exclusion criteria | Children who: 1. Have neurologic disease (an absolute contraindication to the DTP vaccine) 2. Have known or suspected impairment of immunological function 3. Have acute illness at the time of inclusion or have fever (rectal temperature ≥38°C) 4. Have already got their first DTP vaccine dose or first Hepatitis B Virus (HBV) dose, or first Haemophilus influenzae type b (Hib) dose 5. Have known or suspected history of severe atopy 6. Are enrolled or scheduled to be enrolled in another clinical trial 7. Have a history of documented invasive pneumococcal disease 8. Have received a corticosteroid therapy or immunoglobulin or blood products since birth 9. Will be unable to attend the schedule visits and to comply with the study procedures |
| Date of first enrolment | 01/05/2005 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Philippines
Study participating centre
Research Institute for Tropical Medicine
Muntinlupa City
1781
Philippines
1781
Philippines
Sponsor information
Research Institute of Tropical Medicine (Philippines)
Research organisation
Research organisation
Department of Health Compound
FILINVEST Corporate City
Alabang
Muntinlupa City
1781
Philippines
| Website | http://www.ritm.gov.ph/ |
|---|---|
"ROR" |
https://ror.org/01g79at26 |
Funders
Funder type
Research organisation
World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
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 | 01/06/2009 | Yes | No |
