Table 3 Studies concerning the safety of hexavalent vaccine co-administered with other types vaccine in pre-term infants
Author (year) | Study design | Number of children | Gestational age (EG) in weeks (s) | seat | Vaccine | Target | Follow-up (FU) after the vaccine | Results | Bias |
|---|---|---|---|---|---|---|---|---|---|
Wilińska et al. (2016) | Observational perspective | 138 | 73 ≤ 28 s 65 > 28 s | Poland | DTPa, IPV, HBV, Hib, Co-administration: PCV7 | Evaluate incidence of adverse events after vaccination by monitoring CR parameters and body temperature | 72 h | • Apnea and reactivity alterations are the most frequent adverse events (4 and 9% respectively) • Those born preterm who present apnea ano have experienced in a statistically more mind frequently lateonset sepsis (p = 0.028) and a more prolonged use of continuous positive air pressure (CPAP) (p = 0.033) | • No group of control • Limited sample |
DeMeo et al. (2015) [42] | Multi-center cohort retrospective | 13.926 | ≤ 28 s | United States of America | DTPa, IPV, HBV, Hib Co-administration: PCV7 | Evaluate the number of tests for sepsis (blood culture sampling), the increased need for respiratory support, convulsions and death in 3 days after the vaccination | 3 days | • The incidence of findings for sepsis and the need for respiratory support increases after vaccination • Children with an EG of 23–24 weeks demonstrate an increased incidence of sepsis tests and an increased need for respiratory support compared to children with major EG (2728 weeks) • Gram-positive + A history of sepsis is associated with a hearing ished fre ence of investigations for sepsis after vaccine administration | • Healthy vaccinated effect • Clinicians more readily document adverse events that occur in the immediate vicinity of the vaccine administration |
McCrosan et al. (2015) | retrospective tivo | 344 | < 37 s | Ireland | DTPa, IPV, HBV, Hib, Co-administration: PCV7 | Evaluate the safety of preterm vaccines | No child presented adverse events | • Studio retrospotting scope • Not clear the period of follow-up | |
Anderson et al. (2012) | retrospective tivo | 203 | ≤ 28 s | Auslia | DTPa, IPV, HBV, Hib, Co-administration: PCV7 | Evaluate apnea in the 48 h following vaccination to 2 months of life | 48 h | • 17 preterm have presented a framework clinically compatible with apnea (incidence 8.4%) after vaccinations nation than 2 months • Children who have experienced apnea at 2 months of age have a statistically significant lower EG and a lower birth weight • No reaction to subsequent vaccination doses | • Limited sample • Lack of cardio-saturimetric monitoring in 50% of cases at the 4 month vacine dose |
Clifford V et al. (2011) [39] | Retrospect vo observational | 46 | 38 < 37 s 8 ≥ 37 s | Auslia | DTPa, IPV, HBV, HiB, Co-administration: PCV7, rotavirus | • Evaluate the occurrence of adverse events in the 48 h following the vaccine at 2 and 4 months of life • Investigate any risk factors for apnea recurrence | 48 h | • 35/38 preterm has apnea after the 2 month vaccine, 3/38 after the 4-month vaccine • 7/38 (18%) has a recurrence of apnea • A lower birth weight (p = 0.04) and hospitalization due to complications related to prematurity (p = 0.01) increased no risk of recurrence of apnea • No child with recurrent apnea post-vaccination at four months has presented an apnea after the third vaccine dose than 6 months | • Limited sample • Studio retrospotting scope |
Furck et al. (2010) | Observational perspective | 473 | < 37 s | Germany | DTPa, Hib, HBV, IPV Co-administration: PCV7 | Evaluate the adverse events within the next 48 h the vaccine | 48 h | • The frequency of adverse events is 10.8 and 2.8% for apnea / bradycardia and local / fever reactions, respectively • Incidence of apnea / bradycardia increases in co-administration with PCV7 but not in a statistically significant manner • The risk of experiencing episodes of apnea decreases with increasing EG • Fever is statistically more significant in children with grade 3–4 cerebral haemorrhage or with leucomalacia periven tricular (OR 8.7 and 8.2 respectively) | • The 3 groups do not have the same number of children • The EG at the time of vaccination is reduced with advancing years |
Hacking et al. (2010) | retrospective cohort study | 411 | 27 s | Auslia | DTPa, Hib, HBV, IPV Co-administration: PCV7, rotavirus | Assess the need for support respiratory (CPAP) or of ventilation in positive international pressure sender (IPPV) within 7 days after the vaccine at 2 months | 7 days | • 22/411 (5%) pre-term experience a worsening of respiration in the following 3 days the vaccine attributable only to immunization • Children who needed respiratory support after the disease have a greater previous incidence of sepsis (p = 0.02) and a greater average cumulative time of use of CPAP before the vaccine (p = 0.03) | |
Klein et al. (2010) | Prospective self-controlled case series approach | 83 | 33 < 37 s 50 ≥ 37 s | United States of America | DTPa, Hib, HBV, IPV, Co-administration: PCV7 | Describe the AE 30 days after each vaccination dose confrontandone frequency in pretermiit and born at term | 30 days | • No adverse events reported in the 2 groups • The self-controlled case series analysis showed no increase in adverse events in full-term and preterm births after no vaccination | Limited sample |
Carbone et al. (2008) | Perspective, randomized, controlled, double-blind, multicentric | 197 | < 37 s | United States of America | DTPa, IPV, Hib, HBV | Evaluate the increase in CR events after vaccination in preterm | 48 h | No increase in CR events in the vaccine group compared to the control group | No long-term follow-up in the control group |
FlatzJequier et al. (2008) [40] | retrospective tivo | 135 | < 32 s | Switzerland | DTPa, IPV, HiB, HBV, Co-administration: PCV7, anti VRS | Evaluate the frequency of CR events later hexavalent vaccination in VLBW children in the next 48 h the second dose of vaccine | 48 h | • 34/135 VLBW (25%) presented a CR event after a 2-month vaccination dose • 6/33 who had had a reaction after the 1 -day dose needed a medical intervention (eg oxygen supplementation, tactile stimulation, mask ventilation) after the vaccine at 4 months • No children showed a CR event after the third vaccine dose. • A similar p recourse CR post vaccinations final event is the factor risk of recurrence | Retro-view study |
Klein et al. (2008) | retrospective tivo | 497 | 456 ≤ 30 s 41 31–41 s | United States of America | DTPa, IPV, HBV, Hib Co-administration: PCV, in fluence | Evaluate the factors associated with post-vaccination apnea | 48 h | • 95% post-vascular apnea (62/65) occurs in preterm born ≤31 weeks of EG • The bivariate analysis shows that the presence of pre-vaccination apnea is markedly associated with the appearance of post-vaccinal apnea (p < 0.0001) • Multivariate analysis found that a SNAP-II > 10 (AOR: 4.2; 95% CI: 1.2–14.3), the chronological age < 67 days (AOR: 2.3; 95% IC: 1.1–4.8) and weight < 2 kg (AOR: 2.1; 95% CI: 1–4.5) They are associated with the apneas post-vaccinal | |
Omenaca et al. (2012) | Prospective, multicentric, randomized, controlled, double-blind trial | 250 | ≥ 27 < 37 | France, Portugal, Poland, Spain | Rotavirus Co-administration: DTPa, IPV, Hib, HBV | Evaluate the incidence of adverse events at 15 and 31 days after vaccination and any serious adverse events | 31 days | • Similar frequency of adverse events reported in the vaccine group and in the placebo group (p = 0.266) • In the 31 days following the vaccination dose is STAto reported at least one adverse event in both the vaccinated for rotavirus group than in the group placebo • The percentage of all adverse events including those of grade 3 reported 15 days after the vaccine is similar in both groups (p > 0.05) with irradiation as the most common event | |
Omeñaca et al. (2011) | Prospective trial | 286 | 50 27–30 s 87 31–36 s 149 ≥ 37 s | Spain, Greece | PHID-CV Co-administration with DTPa, IPV, Hib, HBV | Evaluate the safety of PHiD-CV e of vaccines co-administered with 2–4-6 months and 16–18 months Evaluate the local and systemic adverse events 31 days after the vaccine dose and serious adverse events within 6 months following the booster dose | 31 days (6 months for severe adverse events) | • The most frequently observed systemic adverse events are irritability, drowsiness, fever and loss of appetite, but the incidence of high-grade systemic adverse events is low (eg 0.8–1.5% with regard to fever> 39 °C in the 4 days following the doses of the primary cycle, 7.1% as regards the subsequent one the booster dose) • The incidence of grade 3 local adverse events is low (< 5.3%) in both groups but greater after the booster dose in full-term births • No severe adverse events were reported to be correlated with the vaccine • It was noted an episode of apnea in preterm infants after the first dose vacSino but has not been considered to be related to the vaccine and left no sequelae |