BACKGROUND:The direct impact of 13-valent pneumococcal conjugate vaccine (PCV13) on colonization with unique PCV13 serotypes and the uptake of vaccine necessary to create indirect protection in ...nonimmunized children were assessed.
METHODS:Carriage surveillance among children <60 months began in July 2010 at a pediatric practice in Boston, MA. Children had nasopharyngeal cultures and parents completed questionnaires detailing demographics and health status. Concurrently, we monitored uptake of PCV13 in children in the community. Children were classified as “presumed immune” or “presumed nonimmune” based on age and PCV13 immunizations received. We assessed trends using adjusted prevalence rates calculated within rolling, 25-week, consecutive intervals.
RESULTS:Between July 2010 and June 2012, 1050 S. pneumoniae isolates were recovered from 1042 children. Eighty-nine isolates (8.5%) were 1 of 6 unique PCV13 serotypes. The expected fall/winter peak in PCV13 carriage was observed in nonimmune children, but was blunted in immune children. There was a 74% reduction in PCV13 colonization in immune compared with nonimmune children. We document a 50% or more decline in the PCV13 carriage in nonimmune children, at the time when the approximately 75% or more of the community children had received PCV13 and were considered immune. During the study, the difference in PCV13 serotype colonization prevalence in nonimmune and immune children disappeared. No evidence of replacement has been observed to date.
CONCLUSIONS:The direct impact of PCV13 on colonization was demonstrated. Evidence of indirect protection in unimmunized (nonimmune) children was observed as vaccine uptake reached 75% in the target community.
Prophylactic vaccination of 16- to 23-year-old females with a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine has been shown to prevent type-specific human ...papillomavirus infection and associated clinical disease. We conducted a noninferiority immunogenicity study to bridge the efficacy findings in young women to preadolescent and adolescent girls and boys, who represent a primary target for human papillomavirus vaccination.
We enrolled 506 girls and 510 boys (10-15 years of age) and 513 females (16-23 years of age). Participants were vaccinated on day 1, at month 2, and at month 6, and serology testing was performed on day 1 and at months 3 and 7 on blinded samples. Neutralizing antibody concentrations were determined using type-specific immunoassays and summarized as geometric mean titers and seroconversion rates. Vaccine tolerability also was assessed.
By month 7, seroconversion rates were > or = 99% for all 4 human papillomavirus types in each group. By month 7, compared with women, anti-human papilloma virus geometric mean titers in girls or boys were noninferior and were 1.7- to 2.7-fold higher. Most (> 97%) injection-site adverse events were mild to moderate in intensity. Significantly more boys (13.8%) and girls (12.8%) than women (7.3%) reported fevers > or = 37.8 degrees C within 5 days of vaccination. Most (96.4%) fevers were mild (< 39 degrees C).
Noninferior immunogenic responses to all 4 human papillomavirus types in the quadrivalent vaccine permit the bridging of efficacy data that were generated in young women to girls. The results in boys lend support for the implementation of gender-neutral human papillomavirus vaccination programs. This vaccine generally was well tolerated.
•Text messaging is a scalable vaccine safety monitoring method.•Non-medically attended event capture is valuable for pandemic influenza vaccination programs.•We captured respiratory symptoms up to 42 ...days post influenza vaccination.•Multi-site text message vaccine safety monitoring is feasible and acceptable.
Using text messaging for vaccine safety monitoring, particularly for non-medically attended events, would be valuable for pandemic influenza and emergency vaccination program preparedness. We assessed the feasibility and acceptability of text messaging to evaluate fever and wheezing post-influenza vaccination in a prospective, observational, multi-site pediatric study.
Children aged 2–11 years old, with an emphasis on children with asthma, were recruited during the 2014–2015 influenza season from three community-based clinics in New York City, and during the 2014–2015 and 2015–2016 seasons from a private practice in Fall River, Massachusetts. Parents of enrolled children receiving quadrivalent live attenuated (LAIV4) or inactivated influenza vaccine (IIV4) replied to text messages assessing respiratory symptoms (day 3 and 7, then weekly through day 42), and temperature on the night of vaccination and the next seven nights (day 0–7). Missing data were collected via diary (day 0–7 only) and phone. Phone confirmation was obtained for both presence and absence of respiratory symptoms. Reporting rates, fever (T≥100.4 °F) frequency, proportion of wheezing and/or chest tightness reports captured via text message versus all sources (text, phone, diary, electronic health record) and parental satisfaction were assessed.
Across both seasons, 266 children were analyzed; 49.2% with asthma. Parental text message response rates were high (>70%) across sites. Overall, fever frequency was low (day 0–2: 4.1% 95% confidence interval (CI) 2.3–7.4%; d3–7: 6.7% 95% CI 4.1–10.8%). A third (39.2%) of parents reported a respiratory problem in their child, primarily cough. Most (88.2%) of the 52 wheezing and/or chest tightness reports were by text message. Most (88.1%) participants preferred text messaging over paper reporting.
Text messaging can provide information about pediatric post-vaccination fever and wheezing and was viewed positively by parents. It could be a helpful tool for rapid vaccine safety monitoring during a pandemic or other emergency vaccination program.
Trial registration: clinicaltrials.gov Identifier: NCT02295007.
BACKGROUND:Seven valent pneumococcal conjugate vaccine (PCV7) was licensed and introduced in 2000 for universal administration of children younger than 2 years of age and for selective immunization ...of children 2–5 years of age.
SPECIFIC AIMS:To identify changes in colonization and antimicrobial susceptibility among Streptococcus pneumoniae organisms after introduction of PCV7.
METHODS:Infants and children ages 2–24 months were enrolled in surveillance study of nasopharyngeal carriage of S. pneumoniae. Nasopharyngeal cultures for S. pneumoniae were performed at all well child visits and illness visits of children with acute otitis media. S. pneumoniae organisms were serotyped, and antimicrobial susceptibilities to penicillin, amoxicillin, trimethoprim-sulfamethoxazole and azithromycin were performed.
RESULTS:During the 3-year period (October 2000 through September 2003), nasopharyngeal colonization with vaccine serotypes declined from 22% to 2%, and nonvaccine serotypes increased from 7% to 16%. Rates of antibiotic resistance of S. pneumoniae isolates to penicillin, amoxicillin, azithromycin and trimethoprim-sulfamethoxazole were 29.3, 2.2, 26.5 and 28.1%, respectively.
CONCLUSIONS:PCV7 immunization produces a marked decline in vaccine serotypes carried in the nasopharynx of young children, with a coincident rise in the prevalence of nonvaccine serotypes. Important shifts in antimicrobial susceptibility have not been observed to date.
Highlights ► Plausible risk intervals are critical for the validity of vaccine safety research. ► We propose a 0–48 h interval to study febrile seizure after certain vaccines. ► We propose a 2–42 ...days interval to study ADEM after immunization. ► Many methodologic issues in selecting plausible intervals have to be considered.
From 1989 to 1998, the incidence of pertussis increased in Massachusetts adolescents and adults, reaching 71 and 5 per 100,000, respectively, by 1998, whereas the incidence in children remained ...stable. By 1998, 92% of cases occurred in adolescents and adults. Nationally, in contrast, adolescents and adults had incidences of only 5 and 0.8 per 100,000, respectively, and accounted for 47% of cases. The availability of a specific serologic test and active surveillance by public health personnel in Massachusetts are at least partial explanations. The rise in incidence may be real, however, because, as diagnostic efforts increased, the percentage of patients with a positive serologic test result also increased. Cases identified in adolescents and adults were quite severe: 83% and 87%, respectively, experienced paroxysmal cough, 45% and 41% experienced vomiting, and 41% and 52% experienced a cough lasting >4 weeks. Administration of acellular pertussis vaccine in these age groups could prevent this substantial morbidity.
Highlights ► We reviewed 212 neurological SAEs after H1N1 vaccine reported to VAERS. ► We applied modified WHO causality criteria to case reports. ► The most frequent diagnoses were GBS (37%) and ...seizure (11%). ► Causal assessment resulted in 72 possible, 108 unlikely, and 20 unrelated to vaccine.
BACKGROUND:Nontypeable Haemophilus influenzae (NTHi) causes otitis media, sinusitis, and likely lower respiratory tract infections in children. Colonization, strain diversity, transmission, and ...antimicrobial susceptibility have implications for both children and their caregivers.
METHODS:For 13 months, we conducted a cross-sectional study of NTHi colonization. Upper respiratory tract cultures were performed in 273 infants and children 2 to 26 months of age and their primary caregivers. NTHi isolates were characterized by multilocus sequence typing (MLST), and antibiotic resistance was examined.
RESULTS:Of the 273 infants, 44 (16.1%) were colonized with NTHi. Prevalence of NTHi varied from 14% in infants less than 6 months of age to 32% in infants between 19 and 26 months of age (P = 0.003). NTHi-colonized infants were more likely to attend day care (30% vs. 12%), have a recent respiratory infection (68% vs. 38%), have recently taken an antibiotic (27% vs. 9%), and have a primary caregiver who reported asthma (11% vs. 1%), compared with other infants (P < 0.01). In the 44 infants colonized with NTHi, we identified 33 different MLSTs. Of the 44 infant–primary caregiver dyads, 9 (20.5%) were colonized with NTHi, and 7 of these 9 shared identical NTHi strains. We also found beta-lactamase–negative NTHi with minimum inhibitory concentrations >2 μg/mL for amoxicillin and beta-lactamase–positive NTHi with minimum inhibitory concentrations >2 μg/mL for amoxicillin clavulanate.
CONCLUSIONS:We found substantial diversity by MLST analysis among NTHi isolates from this community. Infant–primary caregiver dyads usually carried the same strain of NTHi, suggesting that infant–primary caregiver transmission is occurring.
Highlights ► In 87% adverse events following immunization, causality could be assessed. ► Reviewers classified AEFI as definitely causal only rarely (3%). ► A majority of AEFI were deemed either ...unlikely (20%) or not related (33%) to vaccine.
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