Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Ron Dagan


Contact details

Pediatric Infectious Disease Unit
Soroka Medical Center
P.O. Box 151
+972 8 6400 547

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


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


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Healthy children


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



Not Specified

Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment


Trial participating centre

Pediatric Infectious Disease Unit

Sponsor information


Individual Sponsor (Israel)

Sponsor details

Prof Ron Dagan
Pediatric Infectious Disease Unit
Soroka Medical Center
P.O. Box 151
+972 8 6400 547

Sponsor type

Not defined



Funder type


Funder name

Wyeth Pharmaceuticals Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

2010 results in

Publication citations

  1. 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.

Additional files

Editorial Notes