NCT01097941

Effect of Age and Prior Immunity on Response to H1N1 Vaccines in Children

Evaluation of the Effect of Age and Prior Immunity on the Response to Live or Inactivated A/California/07/09 H1N1 Influenza Vaccines in Children

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 4 Years – 9 Years
• Healthy volunteers: Accepted

Summary

A total of 51 children between the ages of 4 and 9 will be randomized to receive a two dose schedule of either licensed live attenuated A/California/07/09 influenza vaccine (LAIV) or licensed inactivated A/California/07/09 influenza vaccine (IIV) or IIV followed by LAIV separated by 28 days. Children with prior vaccination or natural infection with novel H1N1 influenza will be excluded. Randomization will be stratified by pre-existing HAI titers to the previous winter's seasonal H1N1 A/Brisbane/57/07 reference virus.

Detailed description

The study will be conducted as a randomized, prospective, open-label evaluation of the clinical tolerability, vaccine virus shedding, and serum and mucosal antibody response to vaccination with either live monovalent novel H1N1 influenza vaccine (LAIV) or monovalent inactivated novel H1N1 influenza vaccine (IIV) in healthy children between the ages of 4 and 9 years. Children will be screened for antibody to A/Brisbane/57/07 (H1N1) and A/California/07/09 (H1N1) prior to randomization. Children with evidence of prior exposure to the 2009 pandemic H1N1 virus will be excluded. Those with antibodies to A/Brisbane/57/07 (H1N1) will be stratified by preexisting antibody. Vaccine will be administered on days 0 and 28. Safety of vaccination will be assessed using symptoms collected by parents for 7 days after each dose of vaccine. Serum will be obtained prior to and on day 28 following each dose of vaccine and assessed for antibody by HAI, ELISA, B-cell ELISPOT and neutralization techniques. Nasal secretions will be obtained by nasal aspiration prior to and on day 28 after each dose and assessed for HA-specific IgA antibody by ELISA. Nasal swabs will be obtained on days 2, 4, and 7 after each dose of live vaccine and assessed for the presence and magnitude of vaccine virus shedding of the live attenuated vaccine by rtRT-PCR and TCID50 on MDCK cells.

Conditions

• 2009 H1N1 Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Live Attenuated H1N1 Influenza Vaccine	0.2 ml dose of live monovalent vaccine delivered through nasal spray, 2 doses given 28 days apart
BIOLOGICAL	Influenza A (H1N1) 2009 Monovalent Vaccine	0.5 ml IM, 2 doses given 28 days apart
BIOLOGICAL	Influenza A (H1N1) 2009 Monovalent Vaccine/ Influenza A (H1N1) Monovalent Vaccine Live	0.5 ml IM given X1 with 0.1 ml intranasally given 28 days later

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2010-04-02
• Last updated: 2015-09-24

Locations

1 site across 1 country: United States