FeverText: Assessing Fever Rates After Vaccination During the 2011-12 Influenza Season Using Text Messaging

NCT01467934 | Completed Results

• 1 other identifier: AAAJ0504
• Study Type: observational
• Target: 530
• Locations: 1 country
• Sites: 2

Brief Summary

In this study, the investigators will prospectively assess fever rates and other associated vaccine adverse events in 6-23 month old patients during days 0-7 after administration of trivalent inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine (PCV13) concomitantly compared to those who receive trivalent inactivated influenza vaccine (TIV) or 13-valent pneumococcal conjugate vaccine (PCV13) administered non-concomitantly. The investigators hypothesize that fever rates will be significantly higher during the 0-1 days after vaccination when inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine (PCV13) are given concomitantly than when TIV or PCV13 is administered non-concomitantly.

Conditions

Fever

Outcome Measures

Primary Outcomes (1)

• Fever >= 100.4

  8 days

Study Arms (3)

Trivalent inactivated influenza vaccine

Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1

TIV and PCV13 together

Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1

13-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1

Eligibility Criteria

• Age: 6 Months - 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

6-23 months old visiting study sites

You may qualify if:

• are 6 through 23 month olds,
• have a visit at a study site during the study period of Nov. 1, 2011 through March 31, 2012,
• receive trivalent inactivated influenza vaccine (TIV)/13-valent pneumococcal conjugate vaccine (PCV13)concomitantly, trivalent inactivated influenza vaccine (TIV)/without 13-valent pneumococcal conjugate vaccine (PCV13) or 13-valent pneumococcal conjugate vaccine (PCV13) without trivalent inactivated influenza vaccine (TIV)/(4) parent has a cell phone with text messaging capabilities; and
• (5) parent speaks English or Spanish.

You may not qualify if:

• presence of fever \>=100.4 at time of vaccination;
• administration of any antipyretic in the 6-hour period prior to vaccination
• stated intent to use prophylactic antipyretics at time of vaccination before the development of a fever;
• stated intention to move away from the NYC area \<6 month;
• parent only speaks a language other than English or Spanish;
• inability to read text messages;
• children who received live attenuated influenza vaccine (LAIV) this visit;
• children who received trivalent inactivated influenza vaccine (TIV) or 13-valent pneumococcal conjugate vaccine (PCV13) in the seven days prior to enrollment date
• Note: Patient may receive other vaccines in addition to trivalent inactivated influenza vaccine (TIV)/13-valent pneumococcal conjugate vaccine (PCV13)

Sponsors & Collaborators

• Columbia University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (2)

Centers for Disease Control and Prevention

Atlanta, Georgia, 30333, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Related Publications (1)

• Stockwell MS, Broder K, LaRussa P, Lewis P, Fernandez N, Sharma D, Barrett A, Sosa J, Vellozzi C. Risk of fever after pediatric trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccine. JAMA Pediatr. 2014 Mar;168(3):211-9. doi: 10.1001/jamapediatrics.2013.4469.

  PMID: 24395025 DERIVED

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Melissa Stockwell
• Organization: Columbia University

mss2112@columbia.edu

212-342-5732

Study Officials

• Melissa Stockwell, MD MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

• Philip LaRussa, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Karen Broder, MD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics and Population and Family Health

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: November 9, 2011
• Study Start: November 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 21, 2014
• Results First Posted: July 21, 2014

Record last verified: 2014-07

Locations

US (2)