Phase 2 N=35 Prevention

Open-Label Study of H5 Vaccine in Participants of Protocol 04-077

Influenza

Bottom Line

View on ClinicalTrials.gov: NCT00402649 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2008

Primary outcome: Primary: Occurrence of Solicited Adverse Events Among All Subjects — 0; 0; 10; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) (Biological)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Oct 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Occurrence of Solicited Adverse Events Among All Subjects	0; 0; 10; 1; 19; 0	—
PRIMARY Occurrence of the Solicited Adverse Event of Body Aches, Solicited Only From Children Age 6-10	6; 0	—
PRIMARY Occurrence of Unsolicited Adverse Events	2; 0; 2; 0; 2; 0	—
PRIMARY Occurrence of Serious Adverse Events	—	—
SECONDARY Number of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Titers of 1:40 or Greater	7	—
SECONDARY Geometric Mean Titer of Hemagglutination Inhibition Antibody Titers	20.9	—
SECONDARY Number of Participants With a Four-fold or Greater Increase in Hemagglutination Inhibition Antibody Titers	4	—

Summary

This study may provide safety information on a flu vaccine given to children and may provide immunogenicity information to add to what was collected in a previous flu vaccine study. Participants will include 55 healthy children, ages 2-10, who participated in 04-077 and received a placebo injection instead of the flu vaccine or were incompletely immunized. The study has 2 purposes: to make sure there are no serious side effects in children and to see how the immune systems react to the vaccine. Study procedures include up to 4 study visits, up to 9 follow-up phone calls, 2 blood samples to be collected during visits 1 and 3, and up to 3 vaccine injections in the arm or thigh muscle. Parents will be given a memory aid card to record side effects, temperatures, and medications. Parents will have the option for the child to receive a 3rd dose of vaccine if offered, at month 6. This booster shot will require a 6-month visit and participation for an additional 6 months.

Eligibility Criteria

Inclusion Criteria

The subject must be male or female, aged 2 through 10 years at enrollment, and must have participated in protocol 04-077 as a placebo recipient or a subject at the UCLA site.
The subject must be in good health (and not on any chronic medications), as determined by medical history and a history-directed targeted physical examination.
Parents or guardians of the subject must be able to understand and comply with planned study procedures and be available for all study visits.
Parents or guardians of the subject must provide written consent prior to initiation of any study procedures, and subject may provide written assent as appropriate.

Exclusion Criteria

The subject must not have a known allergy to eggs or other components of the vaccine or sensitivity or allergy to latex.
The subject must not have a history of asthma or recurrent wheezing.
The subject must not be undergoing immunosuppression as a result of an underlying illness or treatment.
The subject must not have an active neoplastic disease or a history of any hematologic malignancy.
The subject must not be using oral or parenteral steroids, inhaled steroids, or other immunosuppressive or cytotoxic drugs. Note: Subjects on nasal or topical steroids will be allowed to enroll in this study.
The subject must not have a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
The subject must not receive any other inactivated vaccines within 2 weeks before or after any study vaccine or any other live vaccines within 4 weeks before or after any study vaccine in this study.
The subject must not have an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses (these conditions include, but are not limited to, known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
The subject must not have a history of severe reactions following immunization with contemporary influenza virus vaccines.
The subject must not have an acute illness, including an axillary temperature greater than or equal to 100 degrees F or an oral temperature greater than or equal to 101 degrees F within 3 days prior to vaccination.
The subject must not have received an experimental vaccine or medication within 1 month prior to enrollment in this study, or expect to receive an experimental vaccine, medication, or blood product during the 13-month study period.
The subject must not have any condition that would, in the opinion of the investigator, place them at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
The subject must not have a history of Guillain-Barré syndrome.
The subject must not be participating concurrently in another clinical trial aside from DMID 04-077 (either in active phase or in follow-up phase).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00402649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.