FeverText: Assessing Fever Rates After Influenza and Pneumococcal Vaccination During the 2011-12 Influenza Season Using Text Messaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 530
- 试验地点
- 2
- 主要终点
- Fever >= 100.4
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Exclusion criteria:
- •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)
排除标准
- 未提供
结局指标
主要结局
Fever >= 100.4
时间窗: 8 days
次要结局
未报告次要终点
研究者
Melissa Stockwell, MD, MPH
Assistant Professor of Pediatrics and Population and Family Health
Columbia University