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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01097941
• Date of registration: 30/03/2010
• Primary sponsor: University of Rochester
• Public title: Effect of Age and Prior Immunity on Response to H1N1 Vaccines in Children H1N1Children
• Scientific title: 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
• Date of first enrolment: March 2010
• Target sample size: 51
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01097941
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: John J Treanor, MD
• Affiliation: University of Rochester

Key inclusion & exclusion criteria

Inclusion Criteria:

- Aged between 4 and 9 years, inclusive.

- Pre-vaccination serum HAI titer to A/California/07/09 of 8 or less

- No prior history of laboratory documented infection with novel H1N1 virus or
immunization with novel H1N1 vaccine.

- in good health, as determined by: vital signs (heart rate <140 bpm; blood pressure:
systolic = 90 mm Hg and =140 mm Hg; diastolic = 90 mm Hg; oral temperature <100.0ºF);
medical history; and targeted physical examination, when necessary, based on medical
history. Stable medical condition is defined as: no recent increase in prescription
medication, dose, or frequency of medication in the last 3 months and health outcomes
of the specific disease are considered to be within acceptable limits in the last 6
months.

- subject/parents are able to understand and comply with the planned study procedures,
including being available for all study visits.

- subject/parents have provided informed consent prior to any study procedures. (An
assent will be obtained for all children 6 years and older)

Exclusion Criteria:

- a previous history of vaccination against novel H1N1 virus or a laboratory documented
history of previous novel H1N1 infection.

- History of egg allergy or allergy to other components of vaccine.

- History of wheezing.

- immunosuppressed as a result of an underlying illness or treatment with
immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation
therapy.

- has an active neoplastic disease.

- has long-term (greater than 2 weeks) use of oral or parenteral steroids, or high-dose
inhaled steroids (>800 mg/day of beclomethasone dipropionate or equivalent) within
the preceding 6 months (nasal and topical steroids are allowed).

- received immunoglobulin or another blood product within the 3 months prior to
enrollment in this study.

- 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).

- 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.

- has an acute illness or an oral temperature greater than 99.9 degrees F (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.

- 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.

- 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.

- has a known human immunodeficiency virus, hepatitis B, or hepatitis C infection.

- has a previous history of Guillain-Barré syndrome within 6 weeks of receipt of
influenza vaccination.

- has any condition that the principal investigator (PI) believes may interfere with
successful completion of the study.



Age minimum: 4 Years
Age maximum: 9 Years
Gender: Both

Health Condition(s) or Problem(s) studied

2009 H1N1 Influenza

Intervention(s)

Biological: Influenza A (H1N1) 2009 Monovalent Vaccine

Biological: Influenza A (H1N1) 2009 Monovalent Vaccine/ Influenza A (H1N1) Monovalent Vaccine Live

Biological: Live Attenuated H1N1 Influenza Vaccine

Primary Outcome(s)

The primary endpoint for assessment of the live attenuated vaccine take will be the AUC of the live vaccine virus shedding determined by 50% tissue culture infectious dose (TCID ) on MDCK cells at 33 degrees C [Time Frame: nasal swabs obtained at days 2 post vaccination]

The primary endpoint for assessment of the live attenuated vaccine take will be the AUC of the live vaccine virus shedding determined by 50% tissue culture infectious dose (TCID ) on MDCK cells at 33 degrees C [Time Frame: nasal swab at 4 days post vaccination]

The primary endpoint for assessment of the live attenuated vaccine take will be the AUC of the live vaccine virus shedding determined by 50% tissue culture infectious dose (TCID ) on MDCK cells at 33 degrees C [Time Frame: nasal swab obtained at 7 days post vaccination]

Secondary Outcome(s)

Development of specific local and systemic symptoms occuring after vaccine [Time Frame: for 7 days post each vaccination]

The AUC of nasopharyngeal shedding assessed by quantitative rtRT-PCR [Time Frame: swab obtained at day 4 post vaccination]

The AUC of nasopharyngeal shedding assessed by quantitative rtRT-PCR [Time Frame: swab obtained at day 7 post vaccination]

The AUC of nasopharyngeal shedding assessed by quantitative rtRT-PCR [Time Frame: swabs will be obtained on day 2 post vaccination]

The frequency and magnitude of antibody secreting cell and memory B cells developing after vaccination [Time Frame: on day 35]

The frequency and magnitude of antibody secreting cell and memory B cells developing after vaccination [Time Frame: on day 7]

The frequency and magnitude of hemagglutinin-specific mucosal IgA response assessed by ELISA on nasal secretions [Time Frame: at day 56]

The frequency and magnitude of hemagglutinin-specific mucosal IgA response assessed by ELISA on nasal secretions [Time Frame: day 28]

The frequency and magnitude of serum hemagglutination-inhibition (HAI), ELISA, and neutralizing antibody response to vaccine [Time Frame: at day 28]

The frequency and magnitude of serum hemagglutination-inhibition (HAI), ELISA, and neutralizing antibody response to vaccine [Time Frame: at day 56]

Secondary ID(s)

URMC 09-007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institutes of Health (NIH)