Phase 4
N=34
Effect of Age and Prior Immunity to Response to Seasonal Influenza Vaccines in Children
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT01246999 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Number of Subjects Shedding Vaccine Virus of Each Subtype by PCR — 1; 6; 9; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Live attenuated Influenza vaccine (Biological); Trivalent Influenza Vaccine (Biological); TIV followed by LAIV (Biological); LAIV followed by TIV (Biological)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Shedding Vaccine Virus of Each Subtype by PCR |
1; 6; 9; 1; 5; 9 | — |
| SECONDARY Mean Peak H1N1 Virus Titer, Dose 1 |
1.8; 0.0; 1.4; 0.0 | — |
| SECONDARY Mean Peak H3N2 Virus Titer, Dose 1 |
0.9; 0; 0; 0 | — |
| SECONDARY Mean Peak Influenza B Virus Titer, Dose 1 |
1.6; 0; 2.1; 0 | — |
| SECONDARY Mean Peak H1N1 Virus Titer, Dose 2 |
0.3; 0; 0; 1 | — |
| SECONDARY Mean Peak H3N2 Virus Titer, Dose 2 |
0.3; 0; 0; 0.3 | — |
| SECONDARY Mean Peak Influenza B Virus Titer, Dose 2 |
0; 0; 0; 1.3 | — |
Summary
A total of 88 children between 2 and 9 years of age will be randomized to receive a two dose schedule of either licensed live attenuated trivalent seasonal influenza vaccine (LAIV) or licensed inactivated seasonal influenza vaccine (TIV)or TIV followed by LAIV or LAIV followed by TIV separated by 28 days. Children with a laboratory documented history of prior H1N1 infection will be excluded.
Eligibility Criteria
Inclusion Criteria
- Aged between 2 and 9 years, inclusive.
- No prior history of laboratory documented infection with novel H1N1 virus
- The subject must be in good health, as determined by: vital signs (heart rate 800 mg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).
- The subject received immunoglobulin or another blood product within the 3 months prior to enrollment in this study.
- The subject has received an inactivated vaccine within the 2 weeks or a live vaccine within the 4 weeks prior to enrollment in this study or plans to receive another vaccine within the next 28 days (or 56 days for vaccine naïve recipients).
- The subject has 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 chronic conditions recognized as risk factors for influenza complications or as contraindications for live vaccination, including chronic cardiac (exclusive of hypertension) or pulmonary conditions (including asthma), diabetes mellitus, or renal impairment.
- The subject has an acute illness or an oral temperature greater than 99.9 degreesF (37.7 degrees C) within 3 days prior to enrollment or vaccination. Subjects who had an acute illness that was treated symptoms resolved are eligible to enroll as long as treatment is completed and symptoms resolve > 3 days prior to enrollment.
- The subject is currently participating or plans to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive another experimental agent during participation in this study, or intends to donate blood during the study period.
- The subject has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- The subject has a known human immunodeficiency virus, hepatitis B, or hepatitis C infection.
- The subject has a previous history of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccination.
- The subject has any condition that the principal investigator (PI) believes may interfere with successful completion of the study.
Data sourced from ClinicalTrials.gov (NCT01246999). 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.