Contact information
Type
Scientific
Primary contact
Prof Ron Dagan
ORCID ID
Contact details
Pediatric Infectious Disease Unit
Soroka Medical Center
P.O. Box 151
Beer-Sheva
84101
Israel
+972 8 6400 547
rdagan@bgu.ac.il
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
0887X-101801
Study information
Scientific title
Acronym
Study hypothesis
Number of doses of Prevnar and age of administrration will affect pneumococcal carriage
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
7-valent licensed CRM197 - conjugated pneumococcal vaccine (Prevnar®)
Primary outcome measures
Pneumococcal carriage of Vaccine-type serotypes
Secondary outcome measures
Correlates between carriage and post vaccination antibodies
Overall trial start date
21/07/2005
Overall trial end date
31/07/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
730
Participant 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
Recruitment start date
21/07/2005
Recruitment end date
31/07/2008
Locations
Countries of recruitment
Israel
Trial participating centre
Pediatric Infectious Disease Unit
Beer-Sheva
84101
Israel
Sponsor information
Organisation
Individual Sponsor (Israel)
Sponsor details
Prof Ron Dagan
Pediatric Infectious Disease Unit
Soroka Medical Center
P.O. Box 151
Beer-Sheva
84101
Israel
+972 8 6400 547
rdagan@bgu.ac.il
Sponsor type
Not defined
Website
Funders
Funder type
Industry
Funder name
Wyeth Pharmaceuticals Ltd
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
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20384496
Publication citations
-
Results
Dagan R, Givon-Lavi N, Greenberg D, Fritzell B, Siegrist CA, Nasopharyngeal carriage of Streptococcus pneumoniae shortly before vaccination with a pneumococcal conjugate vaccine causes serotype-specific hyporesponsiveness in early infancy., J. Infect. Dis., 2010, 201, 10, 1570-1579, doi: 10.1086/652006.