Pneumococcal vaccine (PCV10) study
| ISRCTN | ISRCTN56766232 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56766232 |
| Secondary identifying numbers | 2009/04 |
- Submission date
- 13/04/2010
- Registration date
- 07/05/2010
- Last edited
- 24/02/2015
- 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
Prof Andrew Pollard
Scientific
Scientific
University of Oxford
Rm 02-46-07
Childrens Hospital
John Radcliffe
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 234226 |
|---|---|
| andrew.pollard@paediatrics.ox.ac.uk |
Study information
| Study design | Single-centre interventional unblinded randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised open-label immunogenicity study of the 10 Valent Pneumococcal vaccine (PCV10) given as part of the routine infant immunisation schedule to children in Kathmandu, Nepal |
| Study acronym | PCV10 |
| Study objectives | A 2+1 schedule of the 10 valent pneumococcal conjugate vaccine will provide a good serological response and that this will be non-inferior to a 3+0 schedule. |
| Ethics approval(s) | 1. Oxford Tropical Research Ethics Committee (OxTREC) approved on the 4th December 2009 (ref: 61/09) 2. Nepal Health Research Council Ethics Committee approved on the 21st January 2010 (ref: 807) |
| Health condition(s) or problem(s) studied | Pneumococcus |
| Intervention | 1. The proportion of participants with vaccine pneumococcal serotype-specific IgG antibody concentrations greater than or equal to 0.2 micrograms/mL at 18 weeks of age, 1 month following primary immunisation with PCV10 at 6, 10 and 14 weeks (3 + 0 group) and the proportion of participants with vaccine pneumococcal serotype-specific IgG antibody concentrations greater than or equal to 0.2 micrograms/mL at 18 weeks of age, 1 month following primary immunisation with PCV10 at 6 and 14 weeks of age (2 + 1 group) and to demonstrate non-inferiority (within 10% levels) of the 2 + 1 group versus 3 + 0 group for this proportion for each of serotypes 1, 5 and 14. 2. The proportion of participants with vaccine pneumococcal serotype-specific IgG antibodies greater than or equal to 0.2 micrograms/mL at 18 weeks and 10 months of agefor each of the three study groups 3. The proportion of participants with vaccine pneumococcal serotype-specific opsonophagocytic activity greater than or equal to 8 at 18 weeks and 10 months of age for each of the three study groups 4. The vaccine pneumococcal serotype-specific geometric mean IgG antibody concentrations at 18 weeks and 10 months of age in infants in each of the three study groups 5. The vaccine pneumococcal serotype-specific geometric mean opsonophagocytic titres at 18 weeks and 10 months of age in infants in each of the three study groups 6. The proportion of participants in the 2+1 group with vaccine pneumococcal serotype-specific IgG antibody concentrations greater than or equal to 0.2 micrograms/mL prior to receiving a booster at 9 months of age 7. The proportion of participants in the 2+1 group with vaccine pneumococcal serotype opsonophagocytic activity titre greater than or equal to 8 prior to receiving a booster dose of PCV10 at 9 months of age 8. The vaccine pneumococcal serotype-specific geometric mean opsonophagocytic titres and geometric mean IgG antibody concentrations in infants in the 2+1 group prior to receiving a booster dose of PCV10 at 9 months of age 9. The nasopharyngeal pneumococcal serotype-specific carriage rates, at 9 months of age, following immunisation with a PCV10 i.e. post-dose 3 in 3+0 schedule, post-dose 2 in 2+1 schedule and those not receiving the pneumococcal vaccine 10. Protein D-specific IgG antibody geometric mean concentrations in infants in the control and 3+0 groups at the age of 18 weeks and 10 months and in the 2+1 group at the age of 18 weeks, 9 months and 10 months Participants in the 3+0 and 2+1 groups will be followed until 10 months of age and those in the control group will be followed until 11 months of age. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 10 valent pneumococcal vaccine (PCV10) |
| Primary outcome measure | The proportion of participants with IgG antibodies against serotypes 1, 5 and 14 greater than or equal to 0.2 micrograms/mL 1 month post-dose 3 at age of 10 months after receiving PCV10 at 6 weeks, 14 weeks and 9 months (2 + 1 group). |
| Secondary outcome measures | 1. The proportion of participants with vaccine pneumococcal serotype-specific IgG antibody concentrations greater than or equal to 0.2 micrograms/mL at 18 weeks of age, 1 month following primary immunisation with PCV10 at 6, 10 and 14 weeks (3 + 0 group) and the proportion of participants with vaccine pneumococcal serotype-specific IgG antibody concentrations greater than or equal to 0.2 micrograms/mL at 18 weeks of age, 1 month following primary immunisation with PCV10 at 6 and 14 weeks of age (2 + 1 group) and to demonstrate non-inferiority (within 10% levels) of the 2 + 1 group versus 3 + 0 group for this proportion for each of serotypes 1, 5 and 14. 2. The proportion of participants with vaccine pneumococcal serotype-specific IgG antibodies greater than or equal to 0.2 micrograms/mL at 18 weeks and 10 months of agefor each of the three study groups 3. The proportion of participants with vaccine pneumococcal serotype-specific opsonophagocytic activity greater than or equal to 8 at 18 weeks and 10 months of age for each of the three study groups 4. The vaccine pneumococcal serotype-specific geometric mean IgG antibody concentrations at 18 weeks and 10 months of age in infants in each of the three study groups 5. The vaccine pneumococcal serotype-specific geometric mean opsonophagocytic titres at 18 weeks and 10 months of age in infants in each of the three study groups 6. The proportion of participants in the 2+1 group with vaccine pneumococcal serotype-specific IgG antibody concentrations greater than or equal to 0.2 micrograms/mL prior to receiving a booster at 9 months of age 7. The proportion of participants in the 2+1 group with vaccine pneumococcal serotype opsonophagocytic activity titre greater than or equal to 8 prior to receiving a booster dose of PCV10 at 9 months of age 8. The vaccine pneumococcal serotype-specific geometric mean opsonophagocytic titres and geometric mean IgG antibody concentrations in infants in the 2+1 group prior to receiving a booster dose of PCV10 at 9 months of age 9. The nasopharyngeal pneumococcal serotype-specific carriage rates, at 9 months of age, following immunisation with a PCV10 i.e. post-dose 3 in 3+0 schedule, post-dose 2 in 2+1 schedule and those not receiving the pneumococcal vaccine 10. Protein D-specific IgG antibody geometric mean concentrations in infants in the control and 3+0 groups at the age of 18 weeks and 10 months and in the 2+1 group at the age of 18 weeks, 9 months and 10 months |
| Overall study start date | 02/05/2010 |
| Completion date | 31/10/2011 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 40 Days |
| Upper age limit | 60 Days |
| Sex | Both |
| Target number of participants | A total of 390 participants (3+0 group = 120; 2+1 group = 120; control group = 150) |
| Key inclusion criteria | 1. Parent/guardian of participant is willing and able to give informed consent for participation in the study 2. In good health as determined by: 2.1. Medical history 2.2. Physical examination 2.3. Clinical judgement of the investigator 3. Male or female, aged 40 - 60 days at time of first study vaccination 4. Participants residing in Kathmandu 5. Parents able (in the Investigators opinion) and willing to comply with all study requirements |
| Key exclusion criteria | 1. Parent/guardian unwilling or unable to give written informed consent to participate in the study 2. Previous immunisation (excluding BCG and hepatitis B) or planned vaccination during the study period with vaccine not foreseen by this study protocol except influenza vaccine when locally recommended 3. Premature birth (less than 37 weeks gestation) 4. Previous hospital admission 5. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study 6. Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the vaccination, or planned use during the study period 7. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device) |
| Date of first enrolment | 02/05/2010 |
| Date of final enrolment | 31/10/2011 |
Locations
Countries of recruitment
- England
- Nepal
- United Kingdom
Study participating centre
University of Oxford
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
University of Oxford (UK)
University/education
University/education
c/o Heather House
Clinical Trials & Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
England
United Kingdom
| Phone | +44 (0)1865 222757 |
|---|---|
| heather.house@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Industry
University of Oxford (UK)
No information available
GlaxoSmithKline (GSK) (UK)
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 | 01/04/2015 | Yes | No |
