Contact information
Type
Scientific
Contact name
Dr Marilla Lucero
ORCID ID
Contact details
Research Institute for Tropical Medicine
Filinvest Corporate City
Alabang
Muntinlupa City
1781
Philippines
mglucero@pldtdsl.net
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
WHO/RPC032
Study information
Scientific title
Acronym
Study hypothesis
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
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Prevention
Patient information sheet
Condition
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
Overall study end date
31/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Child
Sex
Both
Target number of participants
900
Participant 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
Recruitment start date
01/05/2005
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Philippines
Study participating centre
Research Institute for Tropical Medicine
Muntinlupa City
1781
Philippines
Sponsor information
Organisation
Research Institute of Tropical Medicine (Philippines)
Sponsor details
Department of Health Compound
FILINVEST Corporate City
Alabang
Muntinlupa City
1781
Philippines
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Research organisation
Funder name
World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2009 | Yes | No |