A study comparing the effect of various schedules of the 7-valent licensed CRM197 - conjugated pneumococcal vaccine (Prevnar®) on carriage of Streptococcus pneumoniae in infants and toddlers
| ISRCTN | ISRCTN28445844 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28445844 |
| Secondary identifying numbers | 0887X-101801 |
- Submission date
- 04/07/2005
- Registration date
- 01/09/2005
- Last edited
- 14/04/2010
- 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 Ron Dagan
Scientific
Scientific
Pediatric Infectious Disease Unit
Soroka Medical Center
P.O. Box 151
Beer-Sheva
84101
Israel
| Phone | +972 8 6400 547 |
|---|---|
| rdagan@bgu.ac.il |
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 | Number of doses of Prevnar and age of administrration will affect pneumococcal carriage |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Healthy children |
| Intervention | Group A-D will be randomized using a random number table 1. Group A (n = 175) - will receive the vaccine at 2, 4, 6 and 12 months (The 'Classical' Group) 2. Group B (n = 175) - will receive the vaccine at 2, 4, and 6 months, but no booster will be given at 12 months. A booster dose will be offered at age 30 months, at the end of the follow-up. 3. Group C (n = 175) - will receive the vaccination at 4, 6, 12 months. No dose at 2 months. 4. Group D (n = 175) - will receive the vaccine at 12 and 18 months. This will be the main intervention group. 5. Group E (n = 30) - will receive only 1 dose of PCV7 to document immunogenicity after one dose given at 18 months of age for comparison with group D when PCV7 will be given at 12 and 18 months, so that the effect of booster at 18 months versus the effect of age maturation will be tested. 6. Group F - These are the unvaccinated controls. We have been looking for S. pneumoniae carriage in the various age groups in our populations in the last several years. So far, we collected over 1,200 nasopharyngeal (NP) cultures from healthy children in the community in the last 2.5 years. The carriage rate was similar in the various years, with no remarkable year-to-year variations. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 7-valent licensed CRM197 - conjugated pneumococcal vaccine (Prevnar®) |
| Primary outcome measure | Pneumococcal carriage of Vaccine-type serotypes |
| Secondary outcome measures | Correlates between carriage and post vaccination antibodies |
| Overall study start date | 21/07/2005 |
| Completion date | 31/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Months |
| Sex | Both |
| Target number of participants | 730 |
| Key inclusion criteria | 1. Age: Groups A, B, C, D: 2 m +/- 3 weeks Group E: 18 m +/- 1 m 2. Males or females 3. On time for routine immunization 4. For group E: Received previously 4 doses of Diphtheria, Tetanus, Pertussis (DTP), Haemophilus influenzae type b (Hib) and inactivated polio vaccine (IPV) 5. The parents and legal guardians must understand and be able, willing and likely to fully comply with the study procedures and restrictions 6. The parents and legal guardians must provide written informed consent 7. Patient must be healthy during vaccination procedure |
| Key exclusion criteria | 1. Prematurity of less than 35 weeks 2. Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without a fever. Study vaccines can be administered to persons with a minor illness such as diarrhea or mild upper respiratory infection (URI) without fever (rectal temperature <38.0 °C/100.4 °F). 3. Axillary temperature >38.0 °C/100.4 °F prior to any injection 4. Any clinically important congenital abnormality, any inherited disorder of the metabolism 5. Thrombocytonpenia or any coagulation disorder that would contraindicate intramuscular (im) injection 6. Prior receipt of a licensed or investigational pneumococcal vaccine 7. Chronic (defined as more than 14 consecutive days) use of immunosuppressants or other immune-modifying drugs. For corticosteroids, this is defined as daily systemic therapy with prednisone or its equivalent at a dose of ≥2 mg/day. 8. Known or suspected allergy to any constituent of either product administered in the study 9. Known or suspected intolerance of hypersensitivity, to the study materials (or closely related compounds) or any of the stated ingredients, including diphtheria toxoid and tetanus toxoid 10. Hypotonic-hyporesponsive state within 48 hours after a prior dose of any vaccine 11. Persistent inconsolable crying lasting ≥3 hours within 48 hours after a prior dose of any vaccine 12. Known to be infected with human immunodeficiency virus (HIV) or mother is HIV positive 13. Any other condition or social circumstance (e.g. lack of a telephone, impending relocation) that, in the opinion of the investigator, would make the subject unsuitable or unable to complete the study |
| Date of first enrolment | 21/07/2005 |
| Date of final enrolment | 31/07/2008 |
Locations
Countries of recruitment
- Israel
Study participating centre
Pediatric Infectious Disease Unit
Beer-Sheva
84101
Israel
84101
Israel
Sponsor information
Individual Sponsor (Israel)
Not defined
Not defined
Prof Ron Dagan
Pediatric Infectious Disease Unit
Soroka Medical Center
P.O. Box 151
Beer-Sheva
84101
Israel
| Phone | +972 8 6400 547 |
|---|---|
| rdagan@bgu.ac.il |
Funders
Funder type
Industry
Wyeth Pharmaceuticals Ltd
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 | 15/05/2010 | Yes | No |
