Condition category
Infections and Infestations
Date applied
13/04/2010
Date assigned
07/05/2010
Last edited
24/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andrew Pollard

ORCID ID

Contact details

University of Oxford
Rm 02-46-07
Childrens Hospital
John Radcliffe
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 234226
andrew.pollard@paediatrics.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2009/04

Study information

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

Acronym

PCV10

Study hypothesis

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

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)

Study design

Single-centre interventional unblinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

10 valent pneumococcal vaccine (PCV10)

Primary outcome measures

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 trial start date

02/05/2010

Overall trial end date

31/10/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

A total of 390 participants (3+0 group = 120; 2+1 group = 120; control group = 150)

Participant 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)

Recruitment start date

02/05/2010

Recruitment end date

31/10/2011

Locations

Countries of recruitment

Nepal

Trial participating centre

University of Oxford
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

c/o Heather House
Clinical Trials & Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 222757
heather.house@admin.ox.ac.uk

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Industry

Funder name

University of Oxford (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

GlaxoSmithKline (GSK) (UK)

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25701560

Publication citations

Additional files

Editorial Notes